Actively Recruiting
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
430
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk. Objective: To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers. Eligibility: Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed. Design: Participants will be screened with: Physical exam Blood and urine tests Spinal tap Eye exam Dental exam Heart and lung tests Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed. Bone marrow aspiration and biopsy Some screening tests will be repeated during the study. Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant. Participants will have periodic follow-up visits for 5 years. Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research. Participation will last for 5 years....
CONDITIONS
Official Title
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed high or very high risk hematologic malignancy as defined by the Refined Disease Risk Index for HCT
- Age between 18 and 65 years
- At least one suitable HLA-matched related or HLA-haploidentical donor
- Karnofsky performance score of 60% or higher
- Adequate organ function including cardiac ejection fraction >=45%, lung function tests >=50%, creatinine clearance >=60 ml/min/1.73m2, total bilirubin <=2 times upper normal limit, and liver enzymes <=3 times upper normal limit
- Women of child-bearing potential and men must agree to use effective contraception prior to enrollment and for at least one year post-transplant
- Women of child-bearing potential must have a negative pregnancy test within 7 days prior to enrollment
- Related donors aged 12 years or older, suitable and willing to donate blood, bone marrow, and stool for research
You will not qualify if you...
- Receiving any other investigational agents within 3 weeks prior to conditioning
- Prior myeloablative conditioning for autologous or allogeneic HCT
- Actively breastfeeding
- Active non-hematopoietic malignancy that is metastatic, relapsed/refractory, or locally advanced and not curable (excluding non-melanoma skin cancers)
- Uncontrolled serious illnesses such as severe endocrinopathy, disseminated intravascular coagulation, electrolyte disturbances, active hepatitis, or uncontrolled dental infection judged unsafe for transplantation
- No donor exclusion criteria specified
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amy H Chai
CONTACT
C
Christopher G Kanakry, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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