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RECRUITING
NCT06532552
PHASE2

Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.

Official title: Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2024-07-29

Completion Date

2028-08-01

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

DRUG

VACl

Azacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3.

DRUG

VACh

Azacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days

DRUG

VACl Alternating With VACh

VACl: Azacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3. VACh: Azacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days

DRUG

VA

Azacitidine: 75mg/m2 Subcutaneous (SC) daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28).

Locations (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China