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

NCT ID: NCT06598384

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2030-09-30

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venetoclax combined with Azacytidine

Patients were treated by venetoclax and azacytidine

Group Type: EXPERIMENTAL

Venetoclax combined with Azacytidine

Intervention Type: DRUG

Patients were treated by venetoclax and azacytidine:

Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2 subcutaneous injection qd d1-5.

Interventions

Venetoclax combined with Azacytidine

Patients were treated by venetoclax and azacytidine:

Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2 subcutaneous injection qd d1-5.

Intervention Type: DRUG

Other Intervention Names

VA

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy General Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Liren Qian

Vice Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liren Qian

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Central Contacts

Liren Qian, PhD

Role: CONTACT

qlr2007@126.com

+861066947194

Yu Liu, PhD

Role: CONTACT

+861066947192

Other Identifiers

VAMHCT01

Identifier Type: -

Identifier Source: org_study_id