A Phase 2 interventional study of Total-Body Irradiation and Donor Lymphocyte Infusion in Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Phase 2, Interventional, and Treatment
This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone marrow including normal blood-forming cells (stem cells) and cancer cells. By giving the donor cells in two steps, the dose of lymphocytes given can be tightly controlled and they can be made more tolerant to the body. When the healthy lymphocytes and stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving tacrolimus and mycophenolate mofetil may stop this from happening.
PRIMARY OBJECTIVES:
I. To assess whether providing a patient with "5+5" dosing in a 2 step matched related donor hematopoietic stem cell transplantation (HSCT) increases the percentage of patients who achieve full donor chimerism earlier as defined by 98% or greater donor T cell chimerism at 28 days post HSCT (d+28).
SECONDARY OBJECTIVES:
I. To assess day (d) +90 chimerism in patients receiving "5+5" dosing. II. To assess post HSCT relapse rates in patients receiving "5+5" dosing. III. To assess rates of grade II-IV graft versus host disease (GVHD) in patients receiving "5+5" dosing.
IV. To assess treatment-related mortality (TRM) in patients receiving "5+5" dosing.
EXPLORATORY OBJECTIVES:
I. To assess whether patients receiving "5+5" dosing have lower rates of cytomegalovirus (CMV) reactivation as compared to patients treated on Thomas Jefferson University (TJU) 08D.85 (1st Generation 2-Step Matched Related Trial).
OUTLINE:
CONDITIONING REGIMEN: Patients undergo total body irradiation (TBI) twice daily (BID) on days -9 to -6.
TRANSPLANT: Patients receive donor lymphocytes intravenously (IV) on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Patients undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Patients also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
After completion of study treatment, patients are followed up at days 28, 90, 180, 270, and 365.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's enrollment of 10 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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).
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6. TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI. CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2. TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0. GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Radiation: Total-Body Irradiation · Procedure: Donor Lymphocyte Infusion · Drug: Cyclophosphamide · Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Drug: Tacrolimus · Drug: Mycophenolate Mofetil
Undergo TBI
Also known as: SCT_TBI, TBI, TOTAL BODY IRRADIATION, Whole Body, Whole Body Irradiation, Whole-Body Irradiation
Given IV
Also known as: DLI, Donor Leukocyte Infusion
Given IV
Also known as: (-)-Cyclophosphamide, 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, 2-[bis(b-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane-2-oxide monohydrate, 2-[di(chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide monohydrate, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro, 2-oxide, monohydrate, 6055-19-2, bis(2-chloroethyl)phosphamide cyclic propanolamide ester monohydrate, Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, N,N-bis(2-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate, N,N-bis(2-chloroethyl)-N'-(3-hydroxypropyl)phosphorodiamidic acid intramolecular ester monohydrate, N,N-bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide monohydrate, N,N-bis(b-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate, N,N-bis(beta-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate, N,N-bis(beta-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate, Neosar, Revimmune, Syklofosfamid, WR- 138719
Undergo HSCT
Also known as: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, allogeneic stem cell transplantation, HSC, HSCT, Stem Cell Transplantation
Given IV
Also known as: 109581-93-3, FK 506, Fujimycin, Hecoria, Prograf, Protopic
Given IV
Also known as: 115007-34-6, 128794-94-5, Cellcept, MMF
Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98%
Donor T cell chimerism (defined by 98% or greater donor T cell chimerism) by 28 days post HSCT (d+28). All estimates of rates will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Time frame: At day +28
Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98%
Will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Time frame: At day +90
Relapse Rate
Will be presented with corresponding 95% confidence intervals.
Time frame: At 1 year post-hematopoietic stem cell transplantation (HSCT)
Percentage of Participants With Grades II-IV Graft Versus Host Disease (GVHD)
Will be presented with corresponding 95% confidence intervals.
Time frame: Within 1 year of HSCT
Rate of Treatment-related Mortality (TRM)
Will be presented with corresponding 95% confidence intervals.
Time frame: At 1 year post-HSCT
Rate of Cytomegalovirus
Rate of cytomegalovirus
Time frame: Up to 100 days
| Milestone | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Donor T cell chimerism (defined by 98% or greater donor T cell chimerism) by 28 days post HSCT (d+28). All estimates of rates will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
| percentage of participants | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98% | 22.2 (3 to 60) |
Will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
| percentage of participants | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98% | 50 (16 to 84) |
Will be presented with corresponding 95% confidence intervals.
| Percentage of Participants | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Relapse Rate | 13 (0 to 44) |
Will be presented with corresponding 95% confidence intervals.
| percentage of patients | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Percentage of Participants With Grades II-IV Graft Versus Host Disease (GVHD) | 22 (3 to 53) |
Will be presented with corresponding 95% confidence intervals.
| Percentage of Participants | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Rate of Treatment-related Mortality (TRM) | 11 (0 to 41) |
Rate of cytomegalovirus
| Percentage of Participants | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Rate of Cytomegalovirus | 0 (0 to 98) |
Collected over All patients will be followed for adverse experiences through study completion, an average of 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) | 5/10 (50%) | 7/10 (70%) | 10/10 (100%) |
| Event | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Hypoxia - Grade 3Respiratory, thoracic and mediastinal disorders | 2/10 |
| Syncope - Grade 3Vascular disorders | 2/10 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 2/10 |
| Blood Bilirubin increase - Grade 3Blood and lymphatic system disorders | 1/10 |
| cholecystitis - Grade 3Infections and infestations | 1/10 |
| Delirium - Grade 3Psychiatric disorders | 1/10 |
| Mixed Chimerism - Grade 3Blood and lymphatic system disorders | 1/10 |
| Paricardial effusion - Grade 3Cardiac disorders | 1/10 |
| URI - Grade 3Infections and infestations | 1/10 |
| SepsisInfections and infestations | 1/10 |
| Event | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Alopecia - Grade 1Skin and subcutaneous tissue disorders | 7/10 |
| Dry Mouth - Grade 1Gastrointestinal disorders | 7/10 |
| Vomiting - Grade 1Gastrointestinal disorders | 7/10 |
| Fever - Grade 1General disorders | 6/10 |
| Mucositis - Grade 3Gastrointestinal disorders | 6/10 |
| Sinus Tachycardia - Grade 1Cardiac disorders | 6/10 |
| Abdominal Pain - Grade 1Gastrointestinal disorders | 5/10 |
| Anorexia - Grade 2Metabolism and nutrition disorders | 5/10 |
| Constipation - Grade 1Gastrointestinal disorders | 5/10 |
| Dizziness - Grade 1Nervous system disorders | 5/10 |
| Age, Categorical(Participants) | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Female | 5 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF) |
|---|---|
| United States | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2018 to primary completion in Mar 2025, 78 months.
Results were first posted in Jul 2026, 1 year 4 months after primary completion.
Of 114 non-industry phase 2 interventional studies under Hematologic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 95. This study's 78 months is above that.
Counting every sponsor, half of 136 studies reached it within 57 months; a quarter within 40 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Tacrolimus · Mycophenolic Acid
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University