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

NCT06598384 | Not Yet Recruiting Phase 2

• 1 other identifier: VAMHCT01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Relapse Rate

  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.

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  through study completion, an average of 2 years

• Progression Free Survival (PFS)

  1 year

Study Arms (1)

Venetoclax combined with Azacytidine

EXPERIMENTAL

Patients were treated by venetoclax and azacytidine

Drug: Venetoclax combined with Azacytidine

Interventions

Venetoclax combined with Azacytidine 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.

Also known as: VA

Venetoclax combined with Azacytidine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Liren Qian

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947194; qlr2007@126.com

Yu Liu, PhD

CONTACT

+861066947192

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share