Donor Lymphocyte Infusion After Transplant for Blood Cancers
This study is for people with high-risk blood cancers (hematologic malignancies) who are undergoing a blood or bone marrow transplant. Researchers want to see if giving a "donor lymphocyte infusion" (DLI), which is a type of white blood cell from your donor, shortly after your transplant can lower the chance of your cancer coming back. You would also receive standard medications like Cyclophosphamide, Busulfan, Mycophenolate mofetil, and Fludarabine. The main goal is to find the safest dose of DLI that can be given after different types of transplants. You can join if you are between 12 and 120 years old and have certain high-risk blood cancers.
- Study design
- This is an interventional study planning to enroll 430 participants, but the phase and current status are unclear.
- What's involved
- You would receive a donor lymphocyte infusion on day +7 (or day +21 for a lower dose) after your transplant, along with other medications. The study aims to determine the safest dose of DLI within 60 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of determining the maximally tolerated dose of DLI is measured at 60 days after the transplant.
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NCT05327023
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Recruiting
PHASE1Ages 12+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~430 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:donor lymphocyte infusionCyclophosphamideBusulfanMycophenolate mofetilFludarabineSirolimus
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT
Measured over 60 days
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Christopher G Kanakry, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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%
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/1.73m2 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 highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant.
WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
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.
Exclusion
Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.
Prior myeloablative conditioning for autologous or allogeneic HCT.
Active breastfeeding.
Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers.
Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation.
What this trial measures
- determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT60 days
fraction of evaluable patients who experience steroid-refractory grade III-IV aGVHD at day +60 will be determined and reported along with 80% and 95% two-sided confidence intervals.