Phase 2
N=17
Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation
Acute Myelogenous Leukemia · Acute Lymphoid Leukemia · Juvenile Myelomonocytic Leukemia · Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02458235 ↗Enrolled (actual)
17
Serious AEs
58.8%
Results posted
Oct 2020
Primary outcome: Primary: Relapse Rate — 23.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- azacitidine (Drug); donor lymphocyte infusion (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Rate |
23.5 | — |
| PRIMARY Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events |
— | — |
| PRIMARY Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD) |
0.176; 0.411 | — |
| PRIMARY Proportion of Participants With Serious Infection |
0.41 | — |
| PRIMARY Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure |
0.00 | — |
| PRIMARY Number of Participants Whom Had >2 Dose Reductions for Any Reason |
— | — |
| SECONDARY Median Relapse-free Survival |
22 | — |
| SECONDARY Median Time to Relapse |
3 | — |
Summary
The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT).
Eligibility Criteria
Inclusion Criteria
- Patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell transplant
- Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
- Patients with juvenile myelomonocytic leukemia (JMML)
- Patients with myelodysplastic syndrome (MDS)
Exclusion Criteria
- Patients who have had a prior transplant.
- Patients with Fanconi anemia or other cancer-predisposition syndromes
- Patients with expected survival <12 weeks
- Lansky score <60%
Data sourced from ClinicalTrials.gov (NCT02458235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.