Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Children’s Hospital of Orange County; Hellman Foundation; Johns Hopkins All Children's Hospital; Lucile Packard Children's Hospital
• Treatments: Azacitidine

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%