Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Azacitidine; Decitabine; Venetoclax

Criteria

Inclusion Criteria:

1. Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation; 2. patients with AML must have one of the following high-risk factors:

1. Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML.

2. require more than 2 courses of induction chemotherapy to reach complete remission.

3. Extramedullary myeloid malignancy.

4. ≥CR2

5. Presence of measurable residual disease at the time of HSCT. * 3. patients with MDS must have one of the following high-risk factors:

(1)IPSS-R scores are defined as high-risk or very high-risk. (2)Presence of TP53 mutation. (3)Presence of measurable residual disease at the time of HSCT. * 4.CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L； 5. 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:

1. Blast percentage in bone marrow detected by flow cytometry ≥0.01%

2. Presence of fusion gene or mutated gene by qPCR.

Exclusion Criteria:

1. concurrent use of targeted drugs ; 2. resistant to Venetoclax before transplantation; 3.allergic to decitabine , Azacitidine or venetoclax; 4. active grade II or higher acute GVHD ; 5. active moderate or severe chronic GVHD ; 6. 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: 7.CBC: ANC < 1.0 × 10e9/L, or PLT < 50 × 10e9/L； 8. Severe organ dysfunction:

1. Elevated Aspartate transaminase (AST) /alanine transaminase (ALT), or direct bilirubin >3 times upper limit of normal.

2. Creatinine clearance (Ccr)<50mL/min or serum creatinine >1.5 times upper limit of normal, whether hemodialysis treatment is performed; 9. Active uncontrolled systemic fungal, bacterial, or viral infection 10. Pregnant or lactating women; 11. Other severe complications and not suitable judged by researchers.