Study of Demethylating Agents Combined With Venetoclax to Prevent Relapse in High-risk T-cell Lymphoblastic LeukemiaLymphoma After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the use of demethylating agents combined with venetoclax to prevent relapse in patients with high-risk T-cell lymphoblastic lymphomaleukemia T-LBLALL after they have received allogeneic hematopoietic stem cell transplantation allo-HSCT. This phase II clinical trial aims to assess the effectiveness and safety of this combination treatment compared to historical patients who did not receive prophylactic therapy. The study focuses on improving relapse-free survival and other important outcomes for these high-risk patients. Participants in the experimental group receive combination therapy including venetoclax at a dose of 400 mg daily by mouth for days 1 to 7 of each 28-day cycle. Patients without TP53 mutation are given azacitidine at 32 mgm2 by injection on days 1 to 5 of each cycle, while those with TP53 mutation receive decitabine intravenously at 5 mgm2 on days 1 to 5. This treatment is given in cycles and compared to historical control patients who received transplantation but no preventative treatment. During the study, participants are monitored regularly for relapse-free survival at one and two years, as well as relapse incidence, overall survival, and graft-versus-host disease relapse-free survival. Safety is assessed by tracking adverse events at the end of each 28-day treatment cycle. Blood counts and other lab tests are performed to ensure patient health, and the study duration extends up to several years to capture long-term outcomes and potential risks.

Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention