An interventional study of chemotherapy and total-body irradiation in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Fred Hutchinson Cancer Center. Completed at 5 sites in 3 countries. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Treatment
Among 11 studies testing Mycophenolic Acid in Lymphoma, Extranodal NK-T-Cell — none open to participants now, none under way, none of them phase 3. Mycophenolic Acid · Lymphoma, Extranodal NK-T-Cell.
Among the 11 studies testing Mycophenolic Acid in Lymphoma, Extranodal NK-T-Cell, this one is the 2nd largest by enrollment, is the only one that started in 1997, is one of 2 with no phase, and was the 1st registered.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
Browse Lymphoma, Extranodal NK-T-Cell studies →None of the 11 studies testing Mycophenolic Acid in Lymphoma, Extranodal NK-T-Cell is open now. The open studies under Lymphoma, Extranodal NK-T-Cell, anywhere →
Mycophenolic Acid: first FDA approval 1995 (CELLCEPT), first EMA approval 1996. What it is approved for, and how studies give it, is on its page →
Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 50 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 8
First in 1997; this study’s year is marked. 1 started in 1997.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Median enrollment 23 across the 11 interventional studies. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 4 most frequent:
Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center: none open now, none under way, none of them phase 3. Of 14 finished, 9 (64%) have results posted.
Among the 15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center, this one is the 3rd largest by enrollment, is the only one that started in 1997, is one of 4 with no phase, and was the 1st registered.
Fred Hutchinson Cancer Center’s Lymphoma, Extranodal NK-T-Cell studies by the year they started, since 1997.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing Mycophenolic Acid in Lymphoma, Extranodal NK-T-Cell, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Fred Hutchinson Cancer Center’s 15 in Lymphoma, Extranodal NK-T-Cell:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood stem cell transplant followed by donor lymphocyte infusion in treatment patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When healthy 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. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PRIMARY OBJECTIVES:
I. To determine whether mixed hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen in patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and multiple myeloma.
II. To determine whether mixed chimerism, established with non- myeloablative conditioning regimens, can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes (DLI).
OUTLINE:
CYTOREDUCTION: If necessary, patients with advanced malignancies undergo cytoreductive chemotherapy to reduce tumor size at discretion of primary physician and study investigators.
CONDITIONING REGIMEN: Patients undergo low-dose total-body irradiation followed by allogeneic peripheral blood stem cell (PBSC) transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine intravenously (IV) twice daily (BID) on days -1 to 0 and then orally (PO) BID on days 1-35 with taper to day 56. Patients also receive mycophenolate mofetil PO BID on days 0-27.
POST-TRANSPLANT DLI: Patients with mixed chimerism on day 56 and no evidence of graft-vs-host disease (GVHD) undergo DLI over 30 minutes on day 65 and may receive up to 3 additional infusions in the absence of GVHD and disease progression or persistence. Patients who have not achieved mixed chimerism at day 56 undergo DLI if complete response is not obtained after a 2 month monitoring period.
After completion of study treatment, patients are followed up at 4, 6, 12, 18, and 24 months and then annually thereafter.
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.
Patients \< 66 years of age with other diseases treatable by allogeneic bone marrow transplant (BMT) whom through pre-existing chronic disease affecting kidneys, liver, lungs, and heart are considered to be at high risk for regimen related toxicity using standard high dose regimens; autografting must also be in these patients and they must be approved for this protocol by both PCC and by the principal investigator; the following diseases are the likely candidates but other less common diseases may be considered and approved by PCC:
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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 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.
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.
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 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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
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.
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.
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.
CYTOREDUCTION: If necessary, patients with advanced malignancies undergo cytoreductive chemotherapy to reduce tumor size at discretion of primary physician and study investigators. CONDITIONING REGIMEN: Patients undergo low-dose total-body irradiation followed by allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV BID on days -1 to 0 and then PO BID on days 1-35 with taper to day 56. Patients also receive mycophenolate mofetil PO BID on days 0-27. POST-TRANSPLANT DLI: Patients with mixed chimerism on day 56 and no evidence of GVHD undergo DLI over 30 minutes on day 65 and may receive up to 3 additional infusions in the absence of GVHD and disease progression or persistence. Patients who have not achieved mixed chimerism at day 56 undergo DLI if complete response is not obtained after a 2 month monitoring period.
Drug: chemotherapy · Radiation: total-body irradiation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Procedure: allogeneic hematopoietic stem cell transplantation · Biological: therapeutic allogeneic lymphocytes
Undergo cytoreductive chemotherapy
Also known as: chemo
Undergo TBI
Also known as: TBI
Undergo allogeneic PBSC transplant
Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Given IV or PO
Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune
Given PO
Also known as: Cellcept, MMF
Undergo allogeneic PBSC transplant
Undergo DLI
Also known as: ALLOLYMPH
Incidence of GVHD, myelosuppression, and infections
At the conclusion of the study, all unexpected toxicities will be summarized and reported.
Time frame: Up to 5 years
Greater than 10% incidence of treatment-related mortality (TRM) after PBSC infusion, defined as death without evidence of disease progression
Time frame: Within 65 days of transplant
Greater than 20% incidence of TRM after DLI, defined as death without evidence of disease progression
Time frame: Within 12 months of DLI
Proportion of patients who successfully achieve mixed chimerism
The proportion of patients who successfully establish mixed chimerism in each group (patients with NHL, CLL or multiple myeloma vs patients with other malignancies) will be estimated and corresponding confidence intervals will be presented.
Time frame: Up to 5 years
Proportion of patients with mixed chimerism who successfully achieve full donor chimerism
The proportion of patients with mixed chimerism who are successfully converted to full donor chimerism in each group (patients with NHL, CLL or multiple myeloma vs patients with other malignancies) will be estimated and corresponding confidence intervals will be presented.
Time frame: Up to 5 years
Response of malignancy to DLI
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to 5 years
Incidence of myelosuppression after initial PBSC transplant
Defined as (absolute neutrophil count \[ANC\] \< 500 for \> 2 days, platelets \< 20,000 for \> 2 days). Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to day 56
Incidence of aplasia after DLI
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to day 90
Incidence of grades 2-4 acute GVHD after DLI
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to day 90 post-DLI
Incidence of grades 2-4 acute GVHD after PBSC infusion
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to day 56
Incidence of chronic extensive GVHD after DLI
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to 1 year post-DLI
Dose of cluster of differentiation (CD)3+ cells required to convert mixed to full lymphoid chimeras
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to 5 years
Incidence of non-relapse mortality
Examined separately in the two groups of patients, and reported in a descriptive manner with confidence intervals presented.
Time frame: Up to 5 years
Ran from Sep 1997 to primary completion in Apr 2002, 55 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclosporine · Mycophenolic Acid
Lymphoma, Extranodal NK-T-Cell →
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