At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 17 enrolled

Drug / intervention

azacitidine +1 moredrug

Likely dose

azacitidine 40mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02458235

NCT02458235Phase 2Completed

Compare CT.gov

A Phase II Study of Risk-adapted Donor Lymphocyte Infusion and Azacitidine for the Prevention of Hematologic Malignancy Relapse Following Allogeneic Stem Cell Transplantation

University of California, San Francisco·interventional·Posted Jun 1, 2015·Updated Oct 12, 2020

In Brief

A Phase 2 clinical trial evaluating azacitidine and donor lymphocyte infusion for Acute Myelogenous Leukemia and 3 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Myelogenous Leukemia, Acute Lymphoid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome

CountriesUnited States

CollaboratorsHellman Foundation

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedJun 2015

Enrollment StartJun 2015

Primary CompletionMar 2019

TodayJul 2026

First PostedJun 1, 2015

Enrollment StartJun 2, 2015

Primary CompletionMar 15, 2019

TodayJul 2, 2026

Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

azacitidinedrug

40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals

donor lymphocyte infusionbiological

For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.