Actively Recruiting
Phase I/II Study of Prophylactic Donor Lymphocyte Infusion Early After Transplant with Post-Transplant Cyclophosphamide for High-Risk Blood Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
430
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether giving an infusion of donor lymphocytes early after an allogeneic hematopoietic cell transplant can reduce the risk of relapse in people with high-risk blood cancers such as leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma. The study focuses on patients aged 18 to 65 who have not responded well to standard treatments or have a high risk of relapse. It also involves healthy related donors aged 12 and older. The study is a phase I/II, open-label, single-center trial sponsored by the National Cancer Institute (NCI). Participants will receive myeloablative conditioning chemotherapy and bone marrow transplantation from either HLA-matched-related or HLA-haploidentical donors. Donor lymphocyte infusions (DLI) will be given at escalating doses on day 7 or day 21 after transplant to assess safety and determine the appropriate dose for further study. The trial includes two groups based on donor type, with dose escalation following a standard approach. Additional drugs like cyclophosphamide, busulfan, fludarabine, mycophenolate mofetil, and sirolimus are used for conditioning and graft-versus-host disease (GVHD) prevention. Participants will be monitored closely with physical exams, blood and urine tests, spinal taps, eye and dental exams, heart and lung tests, and imaging scans. Samples of blood, bone marrow, urine, and stool will be collected for research. Participants will remain near the study site for at least 100 days after transplant and have follow-up visits for up to five years to assess safety and outcomes such as GVHD, relapse, survival, and engraftment. Healthy donors will have 2 to 3 visits to provide samples for research. Overall participation may last up to five years.
CONDITIONS
Brief Title
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with high or very high-risk hematologic malignancy suitable for hematopoietic cell transplantation
- Have at least one potentially 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 >=50%, kidney function with estimated clearance >=60 ml/min, and liver enzymes within specified limits
- Women of child-bearing potential and men must agree to use effective contraception prior to study 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 or older deemed suitable and willing to donate blood, bone marrow, and stool for research
You will not qualify if you...
- Receiving any other investigational agents or therapies within 3 weeks prior to conditioning
- Prior myeloablative conditioning for autologous or allogeneic hematopoietic cell transplantation
- Active breastfeeding
- Active non-hematopoietic malignancy that is metastatic, relapsed/refractory, or not curable (excluding non-melanoma skin cancers)
- Uncontrolled serious illness such as severe endocrine problems, blood clotting issues, electrolyte imbalances, active hepatitis, or uncontrolled dental infection
- No exclusion criteria for donors specified
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days (Days -6 through +4)
Participants receive myeloablative conditioning followed by allogeneic hematopoietic cell transplantation with GVHD prophylaxis including post-transplant cyclophosphamide.
Daily visits during conditioning and transplant period
Duration - Single infusion on Day +7 or Day +21 with possible delay up to 4 days if clinically indicated
Participants receive donor lymphocyte infusion on Day +7 or Day +21 to help prevent relapse of hematologic malignancy.
1 infusion visit (in-person)
Duration - Day +5 through Day +70
Participants take immunosuppressive medications including mycophenolate mofetil and sirolimus starting shortly after transplant to prevent graft-versus-host disease.
Regular visits for medication monitoring during this period
Duration - Up to 1 year post-transplant
Participants are monitored for development of acute and chronic graft-versus-host disease, relapse, and overall survival.
Follow-up visits at days +60, +100, +200, and at 1 year
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
C
Christopher G Kanakry, M.D.
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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