Actively Recruiting
Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma/Leukemia After Transplantation
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-05-07
59
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 lymphoma/leukemia (T-LBL/ALL) 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 mg/m2 by injection on days 1 to 5 of each cycle, while those with TP53 mutation receive decitabine intravenously at 5 mg/m2 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.
CONDITIONS
Brief Title
Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 55 years, male or female.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation for T-cell lymphoblastic lymphoma or leukemia.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Blood counts with absolute neutrophil count (ANC) ≥ 1.0 x 10⁹/L and platelets (PLT) ≥ 50 x 10⁹/L.
- Presence of at least one high-risk factor such as age at diagnosis ≥ 35 years, high white blood cell count at diagnosis, elevated LDH, bone marrow involvement with blast cells ≥ 5%, bulky mediastinal mass, early T-cell precursor immunophenotype, poor remission after induction chemotherapy, residual lesions before transplantation, or specific gene mutations related to high risk.
You will not qualify if you...
- Central nervous system involvement at any disease stage.
- Incomplete remission before transplantation.
- Availability of targeted drugs other than study treatment.
- Resistance to BCL-2 inhibitors before transplantation or no improvement after multiple courses.
- Known allergy to demethylating drugs or venetoclax.
- Active acute graft-versus-host disease (GVHD) grade 2 or higher.
- Moderate to severe chronic GVHD.
- Relapse of T-LBL/ALL or transplant rejection with donor cell chimerism less than 95%.
- Blood counts with ANC less than 1.0 x 10⁹/L or platelets less than 50 x 10⁹/L.
- Severe organ dysfunction including liver or kidney impairment.
- Severe active infections.
- Pregnant or breastfeeding women.
- Currently receiving other investigational drugs.
- Any other complications that may pose additional risks as assessed by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive combination therapy with venetoclax and a demethylating agent (either azacitidine or decitabine) in 28-day cycles to prevent relapse after transplantation.
Visits at the start of each 28-day treatment cycle
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xianmin Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here