Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
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....
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 16, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Procedure: donor lymphocyte infusion; Drug: Cyclophosphamide; Drug: Busulfan; Drug: Mycophenolate mofetil; Drug: Fludarabine; Drug: Sirolimus
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Inclusion Criteria - Recipient:
- Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:
- Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse
- AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission \[CR\] with minimal residual disease detectable by any modality also will be eligible)
- AML with adverse cytogenetics (complex karyotype with \>= 4 abnormalities) regardless of remission status
- Low risk myelodysplastic syndrome (MDS) (\<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or \>= 4 abnormalities) with induction failure or active relapse
- High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or \< 4 abnormalities) with induction failure or active relapse
- High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or \< 4 abnormalities) regardless of remission status
- Acute lymphoblastic leukemia (ALL) in CR \>= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)
- Chronic myelocytic leukemia (CML) in blast crisis phase
- Hodgkin lymphoma with stable or progressive disease
- Mantle cell lymphoma with stable or progressive disease
- Relapsed Burkitt lymphoma in CR or partial remission (PR)
- Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease
- T-cell NHL with stable or progressive disease
- Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response \[VGPR\], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed
- Age 18-65 years.
- At least one potentially suitable HLA-haploidentical or HLA-matched donor
- Karnofsky performance score \>60%, see Appendix A
- Recipient participants must have adequate organ function as defined below:
- Cardiac ejection fraction \>=45% by 2D ECHO;
- Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \>=50% predicted;
- Estimated serum creatinine clearance of \>=60 ml/minute/1.73m\^2 calculated using eGFR in the clinical lab;
- Total bilirubin \<=2X the upper limit of normal;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=3X the upper limit of normal.
- Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply: --Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (hormonal, surgical, IUD or barrier method of birth control; abstinence) from the start of conditioning regimen through at least one-year posttransplant. For the HLA haploidentical cohort the requirements are the same, however while taking sirolimus and for 12 weeks after the last dose, the birth control must be highly effective (hormonal, surgical, IUD, abstinence).
- WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment. Inclusion Criteria - Donor: -Related donor (age \>=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- National Institutes of Health Clinical CenterBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2026. Always confirm current availability with the study team.