VA as Maintenance Therapy Post Allo-HSCT in MDS and AML

Phase 2

Not yet recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Venetoclax combined with Azacytidine

• Registration Number: NCT06598384
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia.

Detailed Description

The investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia. overall survival (OS), cumulative 1-year relapse- and progression-free survival (RPFS), time to relapse, relapse rate, incidence of acute and chronic GVHD, time to treatment discontinuation will be counted.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01
• Primary Completion: 2030-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
• The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
• Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.
• Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10^9 /L and platelets ≥ 75×10^ 9 /L before treatment.

Exclusion Criteria

• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
• Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax combined with Azacytidine	Venetoclax combined with Azacytidine	Patients were treated by venetoclax and azacytidine

Primary Outcome Measures

Name	Time	Method
Relapse Rate	1 year	Relapse following CR is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, an average of 2 years	OS was defined as time from diagnosis to death from any cause or the last follow-up
Progression Free Survival (PFS)	1 year	For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.