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Recruiting Phase 2 NCT06686108

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

Trial Parameters

Condition T-cell Acute Lymphoblastic Leukemia
Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 59
Sex ALL
Min Age 14 Years
Max Age 55 Years
Start Date 2024-10-30
Completion 2027-10-30
Interventions
Azacitidine (AZA) Days 1 - 5Decitabine (DAC)Venetoclax

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 1.14-55 years old, male,or female. * 2.Patients with allo-HSCT due to T-LBL/ALL, the donor type is not limited. * 3.ECOG score is 0-2 points. * 4.Blood routine: ANC ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L. * 5.One of the following high-risk factors: * a. Age of initial diagnosis ≥ 35 years old. * b. Initial diagnosis of WBC ≥ 100 × 109/L. * c. Initial diagnosis of LDH exceeding the upper limit of normal values. * d. Initial diagnosis of bone marrow involvement (blast cells ≥ 5%). * e. Initial diagnosis of a bulky in the mediastinum (longest diameter ≥ 10cm). * f. ETP immunophenotype. * g. During the induction chemotherapy process, 2 courses did not achieve partial remission and/or 4 courses did not achieve complete remission. * h. Residual lesions before transplantation: Flow cytometry analysis showed that the proportion of abnormal lymphoid cells in the bone marrow was greater than 0.01%; Positive detection of minimal residual lesions in molecular biology; PET-CT scan sh

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