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Alkylating agents

Donor Lymphocyte Infusion for Blood Cancers

Phase 1 & 2
Recruiting
Led By Christopher G Kanakry, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recipient must have at least one potentially suitable HLA-haploidentical or HLA-matched donor
Recipient must have a histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study if donor lymphocytes given early after transplant can reduce the risk of relapse for people with high-risk blood cancers. Healthy donors are also needed.

Who is the study for?
Adults aged 18-65 with high-risk blood cancers like leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that are hard to treat or likely to come back. They need a healthy relative who can donate bone marrow and white blood cells for the study.Check my eligibility
What is being tested?
The trial is testing if giving patients donor lymphocytes (white blood cells) from their transplant donor soon after a bone marrow transplant can lower the chance of cancer coming back. It includes chemotherapy drugs and staying near NIH for monitoring.See study design
What are the potential side effects?
Possible side effects include reactions to donor cells, increased risk of infections due to immune suppression from chemotherapy and other medications used in the process, as well as typical chemo-related issues like nausea, fatigue, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a donor who matches my HLA type.
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My blood cancer is confirmed to be at a high or very high risk.
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I can care for myself but may need occasional help.
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I am between 18 and 65 years old.
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My heart, lungs, kidneys, and liver are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT
Secondary outcome measures
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Steroid-refractory Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of chronic GVHD at 1 year for HLA-matched-related and HLA-haploidentical
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Phase II Efficacy, Cohort 2 (haploidentical)Experimental Treatment6 Interventions
DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)
Group II: Phase II Efficacy, Cohort 1 (matched)Experimental Treatment6 Interventions
DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)
Group III: Phase I Dose Escalation, Cohort 2 (haploidentical)Experimental Treatment6 Interventions
DLI at escalating doses (1 x 10^5 CD3+ cells/kg, 3 x 10^5 CD3+ cells/kg, and 1 x 10^6 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)
Group IV: Phase I Dose Escalation, Cohort 1 (matched)Experimental Treatment6 Interventions
DLI at escalating doses (1 x 10^6 CD3+ cells/kg, 3 x 10^6 CD3+ cells/kg, and 1 x 10^7 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)
Group V: Donor ArmActive Control1 Intervention
Donors for Recipients in Arms 1-4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Fludarabine
2012
Completed Phase 3
~1100
donor lymphocyte infusion
2016
Completed Phase 3
~260
Cyclophosphamide
1995
Completed Phase 3
~3770
Mycophenolate mofetil
2014
Completed Phase 4
~2350
Busulfan
2008
Completed Phase 3
~1120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,451 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Christopher G Kanakry, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,036 Total Patients Enrolled

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05327023 — Phase 1 & 2
Blood Cancers Research Study Groups: Phase II Efficacy, Cohort 2 (haploidentical), Donor Arm, Phase I Dose Escalation, Cohort 1 (matched), Phase I Dose Escalation, Cohort 2 (haploidentical), Phase II Efficacy, Cohort 1 (matched)
Blood Cancers Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT05327023 — Phase 1 & 2
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327023 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
2022. "Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327023.
All > Blood Cancer
~287 spots leftby Jul 2028
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