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

Navy General Hospital, Beijing

Status and phase

Not yet enrolling

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Venetoclax combined with Azacytidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06598384

VAMHCT01

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.