Actively Recruiting
Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-05-07
59
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.
CONDITIONS
Official 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 (allo-HSCT) for T-cell lymphoblastic lymphoma/leukemia.
- ECOG performance score of 0 to 2.
- Blood counts with absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L and platelet count ≥ 50 × 10⁹/L.
- Presence of at least one high-risk factor such as age at diagnosis ≥ 35 years, initial white blood cell count ≥ 100 × 10⁹/L, elevated LDH, bone marrow involvement (blast cells ≥ 5%), bulky mediastinal mass (≥ 10cm), ETP immunophenotype, poor response to induction chemotherapy, residual lesions before transplantation, specific gene mutations, or high-risk genetic subgroups based on NGS.
You will not qualify if you...
- Central nervous system involvement at any time during the disease.
- Failure to achieve complete remission before transplantation.
- Availability of targeted drugs for the patient.
- Resistance to BCL-2 inhibitors before transplantation or lack of improvement after induction therapy containing BCL-2 inhibitors.
- Allergy to demethylating agents 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 below 95%.
- Blood counts with ANC < 1.0 × 10⁹/L or platelet count < 50 × 10⁹/L.
- Severe organ dysfunction including elevated liver enzymes or impaired kidney function.
- Severe active infections.
- Pregnancy or breastfeeding.
- Participation in other investigational drug studies.
- Any complications assessed by researchers that could pose additional risks.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xianmin Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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