A Phase 2 interventional study of e-ATG and Immunosuppression Only Conditioning in Lymphoproliferative Disorders, Autoimmune Lymphoproliferative and Primary T-cell Immunodeficiency Disorders, sponsored by National Cancer Institute (NCI). Active, not recruiting at 2 sites in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Background:
Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to correct T-cell problems in some people.
Objective:
To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with T-cell problems.
Eligibility:
Donors: Healthy people ages 4 and older
Recipients: People the same age with abnormal T-cell function causing health problems
Design:
All participants will be screened with:
Donors will also have an electrocardiogram and chest x-ray. They may have veins tested or a pre-anesthesia test.
Recipients will also have lung tests.
Some participants will have scans and/or bone marrow collected by needle in the hip bones.
Donors will learn about medicines and activities to avoid and repeat some screening tests.
Some donors will stay in the hospital overnight and have bone marrow collected with anesthesia.
Other donors will get shots for several days to stimulate cells. They will have blood removed by plastic tube (IV) in an arm vein. A machine will remove stem cells and return the rest of the blood to the other arm.
Recipients will have:
Background:
Primary Objective:
- Separately by arm: To estimate the percentage of recipients with >50% donor T cell chimerism and graft-failure free survival at day +180 post-HCT
Eligibility:
TCP/D deemed to be of sufficient past severity to warrant HCT that meets at least one of the criteria below:
Design:
RIC arm: e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m\^2/day IV on days -11 and -7, low-dose cyclophosphamide orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2.
-- Subjects will be assigned to the IOC arm if there is significant end-organ dysfunction present and it is felt that a conditioning regimen that includes busulfan would likely be associated with intolerable or life-threatening toxicities for the subject. Subjects will also be assigned to the IOC arm if they possess a deoxyribonucleic acid (DNA) repair defect, telomere maintenance defect, or familial cancer predisposition syndrome that necessitates limiting chemotherapy as much as possible to prevent future cancer risk.
Graft-versus-host disease (GVHD) prophylaxis:
216 studies on the registry are indexed under Lymphoproliferative Disorders; 49 are open to participants now.
This study's enrollment of 71 is above the median of 41 across 173 interventional studies indexed under Lymphoproliferative Disorders.
Browse Lymphoproliferative Disorders studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
T-cell proliferation and/or dysregulation (TCP/D) deemed to be of sufficient past severity to warrant hematopoietic cell transplantation (HCT) that meets at least one of the criteria below:
Adequate end-organ function, as measured by:
EXCLUSION CRITERIA - RECIPIENT:
INCLUSION CRITERIA RELATED DONOR
EXCLUSION CRITERIA - RELATED DONOR:
-None
INCLUSION CRITERIA - UNRELATED DONOR:
-Unrelated donors will be evaluated in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures, available at: http://bethematch.org/About-Us/Global- transplant-network/Standards/, except for the additional requirement of EBV serostatus testing for clinical purposes of donor selection. Note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study. Unrelated donors only enroll if they contribute research specimens, which is optional.
EXCLUSION CRITERIA - UNRELATED DONOR:
-Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP Standards, available at: http://bethematch.org/About-Us/Global-transplant-network/Standards/. Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not automatically exclude the donor and will be reviewed by the PI.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reduced Intensity Conditioning Arm.
Drug: e-ATG · Procedure: Immunosuppression Only Conditioning · Procedure: Reduced Intensity Conditioning · Drug: GVHD Prophylaxis · Procedure: Allogeneic HSC · Drug: Bisulfan · Drug: Prednisone · Drug: Cyclophosphamide · Drug: MMF · Drug: Mesna · Drug: Tacrolimus · Drug: Pentostatin · Diagnostic Test: PFTs · Diagnostic Test: DEXA · Procedure: Bone Marrow Aspirate & Biopsy · Diagnostic Test: EKG · Diagnostic Test: 2D ECHO
Immunosuppression Only Conditioning Arm.
Drug: e-ATG · Procedure: Immunosuppression Only Conditioning · Drug: GVHD Prophylaxis · Procedure: Allogeneic HSC · Drug: Bisulfan · Drug: Prednisone · Drug: Cyclophosphamide · Drug: MMF · Drug: Mesna · Drug: Tacrolimus · Drug: Pentostatin · Diagnostic Test: PFTs · Diagnostic Test: DEXA · Procedure: Bone Marrow Aspirate & Biopsy · Diagnostic Test: EKG · Diagnostic Test: 2D ECHO
Healthy Donor- Donors for recipients in arm 1 or arm 2.
During Immunosuppression Only Conditioning (IOC) and Reduced Intensity Conditioning (RIC).
Also known as: Antithymocyte Globulin (Equine), Atgam
Equine anti-thymocyte globulin (e-ATG) 40 mg/kg intravenous (IV) once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13, Pentostatin:4 mg/m\^2/day IV on days -9 and -5, cyclophosphamide:5 mg/kg orally daily on days -9 through -2.
Also known as: IOC
Equine anti-thymocyte globulin (e-ATG) 40 mg/kg intravenous (IV) once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13, Pentostatin:4 mg/m\^2/day IV on days -11 and -7, cyclophosphamide: 5 mg/kg orally daily on days -11 through -4, Busulfan IV, pharmacokinetically dosed, on days -3 and -2.
Also known as: RIC
High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, Mesna: 25-50 mg/kg weight-based dosing, Tacrolimus 0.02 mg/kg on days +5 through +90, and mycophenolate mofetil (MMF) 15 mg/kg on days +5 through +25.
Also known as: Graft-versus-host disease prophylaxis
Stem cell transplant
Also known as: Allogeneic hematopoietic stem cell (HSC)
During Reduced Intensity Conditioning (RIC).
Also known as: Busulfex, Myleran
During Immunosuppression Only Conditioning (IOC) and Reduced Intensity Conditioning (RIC).
Also known as: Deltasone
During Immunosuppression Only Conditioning (IOC), Reduced Intensity Conditioning (RIC) and Graft-versus-host disease prophylaxis (GVHD).
Also known as: Cytoxan, Neosar
During Graft-versus-host disease prophylaxis (GVHD).
Also known as: Mycophenolate mofetil, CellCept
During Graft-versus-host disease prophylaxis (GVHD).
Also known as: Mesnex, Uromitexan
During Graft-versus-host disease prophylaxis (GVHD).
Also known as: Prograf
During Immunosuppression Only Conditioning (IOC) and Reduced Intensity Conditioning (RIC).
Also known as: Nipent, Deoxycoformycin
Screening ≤4 weeks pretreatment (rx), Day +180 (≤ 14 days), Day +36 (± 21 days), Day +548 (18 months) (± 28 days), and at 2 years and yearly thereafter through +5 years (± 56 days).
Also known as: Pulmonary function tests
Baseline, Day +365 (± 21 days), at 2 years and yearly thereafter through +5 years (± 56 days), and as clinically indicated after hematopoietic cell transplant (HCT).
Also known as: Dual-energy x-ray absorptiometry
Baseline, Day +60 (± 3 days) and Day +365 (±21 days).
Also known as: BM aspirate & bx
Baseline
Also known as: Electrocardiogram
Screening ≤4 weeks pretreatment (rx), Day +180 (≤ 14 days), Day +36 (± 21 days), Day +548 (18 months) (± 28 days), and at 2 years and yearly thereafter through +5 years (± 56 days).
Also known as: 2-dimensional echocardiogram
Percentage of Recipients Who Are Alive With >50% Donor T Cell Chimerism and Graft-failure Free at 180 Days Post Hematopoietic Cell Transplant (HCT) Reported With an 80% Confidence Interval
Percentage of recipients with \> 50% donor T cell chimerism and without death or graft failure. A graft failure event is defined as either primary or secondary graft failure, in the absence of a recurrent marrow malignancy.
Time frame: Day +180 post-HCT
Percentage of Recipients Who Are Alive With >50% Donor T Cell Chimerism and Graft-failure Free at 180 Days Post Hematopoietic Cell Transplant (HCT) Reported With a 95% Confidence Interval
Percentage of recipients with \> 50% donor T cell chimerism and without death or graft failure. A graft failure event is defined as either primary or secondary graft failure, in the absence of a recurrent marrow malignancy.
Time frame: Day +180 post -HCT
Cumulative Incidence of Transplant-related Mortality
Cumulative incidence of transplant-related mortality at 180 days and 1-year post-transplant. Transplant related mortality is defined as any death that occurs outside the setting of the hematopoietic cell transplant (HCT) post-allogeneic relapse of a pre-transplant malignancy or lymphoid disorder.
Time frame: Day +180, and 1-year post-transplant
Cumulative Incidence of Secondary Graft Failure
Cumulative incidence of secondary graft failure at 1-year post-transplant. Secondary graft failure is defined as initial blood or marrow donor myeloid chimerism ≥5%, declining to \<5% on subsequent measurements. \<5% indicates graft failure (undesirable outcome).
Time frame: 1-, 3-, and 5-years post-transplant
Percent Probability of Overall Survival (OS)
OS is defined as the time in whole days from hematopoietic cell transplantation (HCT) to death from any cause, with surviving recipients censored at the time of last contact.
Time frame: 1-, 3-, and 5-years post-transplant
Percentage of Participants Who Achieve Chimerism at Stated Days Between Those Who Have Failed by Day 60 or Have Not
Percentage of participants who achieve early chimerism (\>50% T cell chimerism) at stated days between those who have failed by day 60 or have not. Comparison to be performed using Fisher's exact test. Chimerism is the percentage of donor cells in the peripheral blood.
Time frame: Day +21, +28, +35, +42, and +60 after hematopoietic cell transplant (HCT)
Percentage of Donor T-cell Populations at Days +28, +42, +60, +100, +180, and 1-year Post Hematopoietic Cell Transplant (HCT)
The percentage of donor T-cell populations at days +28, +42, +60, +100, +180, and 1-year post hematopoietic cell transplant.
Time frame: Days +28, +42, +60, +100, +180, and 1-year post hematopoietic cell transplant
Cumulative Incidence of Chronic Graft-versus-host Disease (cGVHD)
Cumulative incidence curves of chronic graft versus host disease and two-sided 95% confidence intervals at 1 and 2-years post -transplant. cGVHD was scored according to the 2014 National Institutes of Health (NIH) Consensus Criteria for Clinical Trials in Chronic GVHD. Eight organs will be scored on a 0-3 scale.
Time frame: 1 and 2-years post-transplant
Cumulative Incidence of Acute Graft-versus-host Disease (aGVHD) at 1 Year
Cumulative incidence curves of acute graft versus host disease and two-sided 95% confidence intervals at 1-year post transplant according to Keystone Criteria of the 1994 Consensus Conference on Acute GVHD Grading. Acute GVHD is defined as any grade, grade 2, 3, or 4 and grade 3-4 acute GVHD. The Keystone criteria provide the basis for grading acute GVHD as follows: Organ-Specific Staging: Each affected organ (skin, liver, gut) is staged 0 (absent) to 4 (severe). Overall Grading (I-IV): Based on the most severe organ involvement. Skin (Grade 0-4): Based on % body surface area (BSA) involvement (e.g., \<25% for Grade 1, \>50% for Grade 3, bullae for Grade 4). Liver (Grade 0-4): Based on total serum bilirubin levels (e.g., 2-2.9 mg/dL for Grade 1, \>15 mg/dL for Grade 4). Gut (Grade 0-4): Based on diarrhea volume and severity (e.g., \>500 mL/day for Grade 1, \>2000 mL/day or ileus/severe pain for Grade 4). Upper GI: Included for classification, with specific criteria for staging.
Time frame: 1-year post-transplant
Percent Probability Event-free Survival (EFS)
EFS is defined as the time from transplant to death of any cause or other event, including disease relapse, graft failure, grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic therapy, or receipt of post-transplant donor cell infusion.
Time frame: 1, 3, and 5-years post-transplant
Cumulative Incidence of Primary Graft Failure at Day +60
Primary graft failure at day +60 estimated using cumulative incidence curves and 95% two-sided confidence intervals. Primary graft failure is defined as \< 5% donor myeloid chimerism in blood and/or bone marrow on all evaluations up to and including day +60, in the absence of a recurrent marrow malignancy.
Time frame: Day +60
Percentage of Participants With Lymphoproliferative Disease/Lymphoma Relapse at 1, 3, and 5-years Post-hematopoietic Cell Transplant (HCT)
Lymphoproliferative disease/lymphoma relapse at 1, 3, and 5-years post-HCT estimated using cumulative incidence curves and two-sided 95% confidence intervals at each timepoint.
Time frame: 1, 3, and 5 years post-HCT
Percent Probability Graft Versus Host Disease (GVHD)-Free Graft Failure-free Survival (GGFS)
Probabilities of GGFS were estimated using the Kaplan-Meier method. GGFS is
Time frame: 1, 3, and 5 years post-hematopoietic cell transplant (HCT)
Percent Probability of Graft Versus Host Disease (GVHD)-Free Relapse-free Survival (GRFS)
GRFS was estimated using the Kaplan-Meier method. Relapse free survival is
Time frame: 1, 3 and 5-years post-hematopoietic cell transplant (HCT)
Cumulative Incidences of Cytomegalovirus (CMV), BK Virus (BK), Adenovirus, Human Herpes Virus 6 (HHV6), JC Virus (JCV), and Epstein-Barr Virus (EBV) Detection in Blood at Day +100 Post-HCT
Cumulative incidences of CMV, BK, adenovirus, HHV6, JCV, and EBV detection in blood at day +100 post-HCT estimated using cumulative incidence curves along with two-sided 95% confidence intervals.
Time frame: day +100 post-HCT
Percentage of Donor B-cell Populations at Days +28, +42, +60, +100, +180, and 1-year Post-transplant
The percentage of donor B-cell populations at days +28, +42, +60, +100, +180, and 1-year post-transplant.
Time frame: Days +28, +42, +60, +100, +180, and 1-year post-transplant
Percentage of Donor Natural Killer (NK-) Cell Populations at Days +28, +42, +60, +100, +180, and 1-year Post Transplant
Percentage of donor natural killer (NK-) cell populations at days +28, +42, +60, +100, +180, and 1-year post transplant.
Time frame: Days +28, +42, +60, +100, +180, and 1-year post transplant
Percentage of Donor Myeloid Cell Populations at Days +28, +42, +60, +100, +180, and 1-year Post Transplant
Percentage of donor myeloid cell populations at days +28, +42, +60, +100, +180, and 1-year post transplant.
Time frame: Days +28, +42, +60, +100, +180, and 1-year post transplant
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Conditioning start until return to baseline/stabilization, 30 days post-therapy end, removal from therapy, or off study, whichever comes first for all AEs, followed by AE collection per principal investigator discretion, on average 2 years.
| Milestone | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors |
|---|---|---|---|---|---|
| Started | 25 | 4 | 10 | 20 | 12 |
| Completed follow-up period | 9 | 1 | 0 | 0 | 6 |
| Completed | 9 | 1 | 3 | 0 | 6 |
| Not completed | 16 | 3 | 7 | 20 | 6 |
| Withdrew: Screen failures | 0 | 0 | 0 | 20 | 0 |
| Withdrew: Death | 4 | 2 | 0 | 0 | 0 |
| Withdrew: Donor is not removed until recipient completes follow up | 0 | 0 | 7 | 0 | 6 |
| Withdrew: Graft failure | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Less than 5 years post-transplant | 12 | 0 | 0 | 0 | 0 |
Percentage of recipients with \> 50% donor T cell chimerism and without death or graft failure. A graft failure event is defined as either primary or secondary graft failure, in the absence of a recurrent marrow malignancy.
| Percentage of participants | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Percentage of Recipients Who Are Alive With >50% Donor T Cell Chimerism and Graft-failure Free at 180 Days Post Hematopoietic Cell Transplant (HCT) Reported With an 80% Confidence Interval | 80 (69.7 to 90.3) | 25 (-2.7 to 52.7) |
Percentage of recipients with \> 50% donor T cell chimerism and without death or graft failure. A graft failure event is defined as either primary or secondary graft failure, in the absence of a recurrent marrow malignancy.
| Percentage of participants | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Percentage of Recipients Who Are Alive With >50% Donor T Cell Chimerism and Graft-failure Free at 180 Days Post Hematopoietic Cell Transplant (HCT) Reported With a 95% Confidence Interval | 80 (64.3 to 95.7) | 25 (-17.4 to 67.4) |
Cumulative incidence of transplant-related mortality at 180 days and 1-year post-transplant. Transplant related mortality is defined as any death that occurs outside the setting of the hematopoietic cell transplant (HCT) post-allogeneic relapse of a pre-transplant malignancy or lymphoid disorder.
| percent of participants | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Day +180 post-transplant | 12 | 50 |
| 1-year post-transplant | 12 | 50 |
Cumulative incidence of secondary graft failure at 1-year post-transplant. Secondary graft failure is defined as initial blood or marrow donor myeloid chimerism ≥5%, declining to \<5% on subsequent measurements. \<5% indicates graft failure (undesirable outcome).
Results for this outcome have not been posted.
OS is defined as the time in whole days from hematopoietic cell transplantation (HCT) to death from any cause, with surviving recipients censored at the time of last contact.
Results for this outcome have not been posted.
Percentage of participants who achieve early chimerism (\>50% T cell chimerism) at stated days between those who have failed by day 60 or have not. Comparison to be performed using Fisher's exact test. Chimerism is the percentage of donor cells in the peripheral blood.
| Percentage of participants | Arm 1: Participants Who Achieved >50% T Cell Chimerism by Day +60 | Arm 1: Participants Who Failed to Achieve >50% T Cell Chimerism by Day +60 | Arm 2: Participants Who Achieved >50% T Cell Chimerism by Day +60 | Arm 2: Participants Who Failed to Achieve >50% T Cell Chimerism by Day +60 |
|---|---|---|---|---|
| (>50% T cell chimerism at +21 days post-HCT | 69 | — | 100 | NA |
| (>50% T cell chimerism at +28 days post-HCT | 85 | — | 100 | — |
| (>50% T cell chimerism at +35 days post-HCT | 83 | — | 100 | NA |
| (>50% T cell chimerism at +42 days post-HCT | 84 | — | 100 | — |
The percentage of donor T-cell populations at days +28, +42, +60, +100, +180, and 1-year post hematopoietic cell transplant.
| percentage T-cells | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Day +28 after HCT | 91 (9 to 100) | 95 (95 to 95) |
| Day +42 after HCT | 97 (0 to 100) | 99.5 (99 to 100) |
| Day +60 after HCT | 97.5 (0 to 100) | 98 (0 to 100) |
| Day +100 after HCT | 98 (56 to 100) | 98 (98 to 100) |
| Day +180 after HCT | 100 (67 to 100) | 100 (100 to 100) |
| Day +365 after HCT | 100 (79 to 100) | 90 (90 to 90) |
Cumulative incidence curves of chronic graft versus host disease and two-sided 95% confidence intervals at 1 and 2-years post -transplant. cGVHD was scored according to the 2014 National Institutes of Health (NIH) Consensus Criteria for Clinical Trials in Chronic GVHD. Eight organs will be scored on a 0-3 scale.
Results for this outcome have not been posted.
Cumulative incidence curves of acute graft versus host disease and two-sided 95% confidence intervals at 1-year post transplant according to Keystone Criteria of the 1994 Consensus Conference on Acute GVHD Grading. Acute GVHD is defined as any grade, grade 2, 3, or 4 and grade 3-4 acute GVHD. The Keystone criteria provide the basis for grading acute GVHD as follows: Organ-Specific Staging: Each affected organ (skin, liver, gut) is staged 0 (absent) to 4 (severe). Overall Grading (I-IV): Based on the most severe organ involvement. Skin (Grade 0-4): Based on % body surface area (BSA) involvement (e.g., \<25% for Grade 1, \>50% for Grade 3, bullae for Grade 4). Liver (Grade 0-4): Based on total serum bilirubin levels (e.g., 2-2.9 mg/dL for Grade 1, \>15 mg/dL for Grade 4). Gut (Grade 0-4): Based on diarrhea volume and severity (e.g., \>500 mL/day for Grade 1, \>2000 mL/day or ileus/severe pain for Grade 4). Upper GI: Included for classification, with specific criteria for staging.
| percentage | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Cumulative Incidence of Acute Graft-versus-host Disease (aGVHD) at 1 Year | 32 (15.2 to 50.2) | 50 (5.8 to 84.5) |
EFS is defined as the time from transplant to death of any cause or other event, including disease relapse, graft failure, grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic therapy, or receipt of post-transplant donor cell infusion.
Results for this outcome have not been posted.
Primary graft failure at day +60 estimated using cumulative incidence curves and 95% two-sided confidence intervals. Primary graft failure is defined as \< 5% donor myeloid chimerism in blood and/or bone marrow on all evaluations up to and including day +60, in the absence of a recurrent marrow malignancy.
| percentage | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Cumulative Incidence of Primary Graft Failure at Day +60 | 0 (0 to 0) | 50 (15.5 to 94.2) |
Lymphoproliferative disease/lymphoma relapse at 1, 3, and 5-years post-HCT estimated using cumulative incidence curves and two-sided 95% confidence intervals at each timepoint.
Results for this outcome have not been posted.
Probabilities of GGFS were estimated using the Kaplan-Meier method. GGFS is
Results for this outcome have not been posted.
GRFS was estimated using the Kaplan-Meier method. Relapse free survival is
Results for this outcome have not been posted.
Cumulative incidences of CMV, BK, adenovirus, HHV6, JCV, and EBV detection in blood at day +100 post-HCT estimated using cumulative incidence curves along with two-sided 95% confidence intervals.
| percent | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| CMV | 44 (27.3 to 65.2) | 25 (3.95 to 87.2) |
| BK | 64 (45.8 to 81.8) | 100 (0 to 100) |
| Adenovirus | 8 (2.06 to 28.4) | 75 (33.5 to 99.1) |
| HHV6 | 57.5 (39.2 to 77.1) | 75 (33.5 to 99.1) |
| JCV | 32 (17.5 to 53.9) | 75 (33.5 to 99.1) |
| EBV | 60 (41.9 to 78.7) | 25 (3.95 to 87.2) |
The percentage of donor B-cell populations at days +28, +42, +60, +100, +180, and 1-year post-transplant.
Results for this outcome have not been posted.
Percentage of donor natural killer (NK-) cell populations at days +28, +42, +60, +100, +180, and 1-year post transplant.
Results for this outcome have not been posted.
Percentage of donor myeloid cell populations at days +28, +42, +60, +100, +180, and 1-year post transplant.
| percentage cells | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease |
|---|---|---|
| Day +28 post-transplant | 100 (78 to 100) | 23 (4 to 42) |
| Day +42 post-transplant | 100 (61 to 100) | 4 (0 to 33) |
| Day +60 post-transplant | 100 (34 to 100) | 3 (0 to 29) |
| Day +100 post-transplant | 100 (56 to 100) | 31 (12 to 50) |
| Day 180 post-transplant | 100 (67 to 100) | 22 (22 to 22) |
| 1-year post-transplant | 100 (92 to 100) | 33 (33 to 33) |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor |
|---|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 25 | 4 | 1 |
Collected over For Arms 1 and 2, recipients, All-Cause Mortality was monitored/assessed, an average of 2 years. All Adverse Events (AEs) were monitored/assessed from the start of conditioning (hematopoietic cell transplant day -14) until return to baseline or stabilization of event, through 30 days after end of therapy, removal from protocol therapy, or until off study, whichever comes first, followed by collection of AEs per principal investigator discretion, an average of 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | 4/25 (16%) | 18/25 (72%) | 25/25 (100%) |
| Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 2/4 (50%) | 4/4 (100%) | 4/4 (100%) |
| 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) |
| Event | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor |
|---|---|---|---|
| HypotensionVascular disorders | 1/25 | 2/4 | 0/10 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/25 | 2/4 | 0/10 |
| Platelet count decreasedInvestigations | 11/25 | 0/4 | 0/10 |
| Neutrophil count decreasedInvestigations | 10/25 | 1/4 | 0/10 |
| White blood cell decreasedInvestigations | 7/25 | 1/4 | 0/10 |
| Abdominal painGastrointestinal disorders | 0/25 | 1/4 | 0/10 |
| Acute kidney injuryRenal and urinary disorders | 1/25 | 1/4 | 0/10 |
| AscitesGastrointestinal disorders | 0/25 | 1/4 | 0/10 |
| BacteremiaInfections and infestations | 5/25 | 1/4 | 0/10 |
| Creatinine increasedInvestigations | 1/25 | 1/4 | 0/10 |
| Event | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor |
|---|---|---|---|
| White blood cell decreasedInvestigations | 19/25 | 4/4 | 0/10 |
| Neutrophil count decreasedInvestigations | 19/25 | 2/4 | 0/10 |
| Infusion related reactionInjury, poisoning and procedural complications | 9/25 | 3/4 | 0/10 |
| AnemiaBlood and lymphatic system disorders | 18/25 | 2/4 | 0/10 |
| Platelet count decreasedInvestigations | 18/25 | 1/4 | 0/10 |
| HypokalemiaMetabolism and nutrition disorders | 15/25 | 1/4 | 0/10 |
| NauseaGastrointestinal disorders | 15/25 | 1/4 | 0/10 |
| Mucositis oralGastrointestinal disorders | 13/25 | 0/4 | 0/10 |
| AnorexiaMetabolism and nutrition disorders | 4/25 | 2/4 | 0/10 |
| HypoalbuminemiaMetabolism and nutrition disorders | 4/25 | 2/4 | 0/10 |
| Age, Categorical(Participants) | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors | Total |
|---|---|---|---|---|---|---|
| <=18 years | 7 | 0 | 0 | 8 | — | 15 |
| Between 18 and 65 years | 18 | 4 | 9 | 12 | — | 43 |
| >=65 years | 0 | 0 | 1 | 0 | — | 1 |
| Age, Continuous(years) | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors | Total |
|---|---|---|---|---|---|---|
| Mean | 26.04 ± 15.1 | 32 ± 12.11 | 35.5 ± 16.16 | 26.35 ± 14.45 | — | 28.15 ± 14.97 |
| Sex: Female, Male(Participants) | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors | Total |
|---|---|---|---|---|---|---|
| Female | 11 | 1 | 3 | 7 | 4 | 26 |
| Male | 14 | 3 | 7 | 13 | 8 | 45 |
| Race/Ethnicity, Customized(Participants) | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors | Total |
|---|---|---|---|---|---|---|
| Ethnicity - Hispanic or Latino | 7 | 0 | 3 | 2 | — | 12 |
| Ethnicity - Not Hispanic or Latino | 17 | 4 | 5 | 17 | — | 43 |
| Ethnicity - Unknown or Not Reported | 1 | 0 | 2 | 1 | — | 4 |
| Race - American Indian or Alaska Native | 0 | 0 | 0 | 0 | — | 0 |
| Race - Asian | 1 | 0 | 1 | 2 | — | 4 |
| Race - Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | — | 0 |
| Race - Black or African American | 1 | 1 | 0 | 3 | — | 5 |
| Race - White | 20 | 3 | 6 | 13 | — | 42 |
| Race - More Than One Race | 1 | 0 | 0 | 0 | — | 1 |
| Race - Unknown or Not Reported | 2 | 0 | 2 | 1 | — | 5 |
| Race - Other | 0 | 0 | 1 | 0 | — | 1 |
| Race - Asian White | 0 | 0 | 0 | 1 | — | 1 |
| Region of Enrollment(participants) | Reduced Intensity Conditioning+Allogeneic Hematopoietic Cell Transplant + Graft-versus-Host Disease | Immunosuppression-Only Conditioning + Allo Hematopoietic Cell Transplant +Graft-versus-Host Disease | 7-8/8 Human Leukocyte Antigen (HLA)-Matched Related or Unrelated, or HLA-haploidentical Donor | Participants Enrolled But Not Treated | National Marrow Donor Program (NMDP) Donors | Total |
|---|---|---|---|---|---|---|
| United States | 25 | 4 | 10 | 20 | 12 | 71 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely. Genomic data is available once genomic data is uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Access criteria: Clinical data will be made available with the permission of the study principal investigator (PI). Genomic data is made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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Studies of the drugs tested here: Antilymphocyte Serum · Busulfan · Prednisone · Cyclophosphamide · Mycophenolic Acid · Mesna · Tacrolimus · Pentostatin
Lymphoproliferative Disorders →
National Cancer Institute (NCI) →