A Single Arm, Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With f High-risk Myeloid Malignancies.

SHSYXY-AZA-VEN-202301

The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .

2023-01-01

2024-12-31

2025-12-31

Recruiting

Early phase I

78

Inclusion Criteria: * Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation; * Patients with AML must have one of the following high-risk factors: Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML； require more than 2 courses of induction chemotherapy to reach complete remission； Extramedullary myeloid malignancy；≥CR2； Presence of measurable residual disease at the time of HSCT. \* * Patients with MDS must have one of the following high-risk factors: IPSS-R scores are high-risk or very high-risk； Presence of TP53 mutation； Presence of measurable residual disease at the time of HSCT. \* * CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L； * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Presence of measurable residual disease at the time of HSCT is defined as the following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%； Presence of fusion gene or mutated gene by qPCR. Exclusion Criteria: * Concurrent use of targeted drugs ; * Resistant to Venetoclax before transplantation; * Allergic to decitabine , Azacitidine or venetoclax; * Active grade II or higher acute GVHD ; * Active moderate or severe chronic GVHD ; * Diseases recurrence (abnormal myeloid cells detected by flow cytometry \>0.01%, presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \<90% or graft rejection: * CBC: ANC \< 1.0 × 10e9/L, or PLT \< 50 × 10e9/L； * Severe organ dysfunction: Elevated Aspartate transaminase (AST) /alanine transaminase (ALT), or direct bilirubin \>3 times upper limit of normal; Creatinine clearance (Ccr)\<50mL/min or serum creatinine \>1.5 times upper limit of normal, whether hemodialysis treatment is performed; * Active uncontrolled systemic fungal, bacterial, or viral infection * Pregnant or lactating women; * Other severe complications and not suitable judged by researchers.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}

2023-05-08