RecruitingPhase 2NCT06532552

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

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


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

172 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares four different treatment combinations for older adults or those who are not fit enough for intensive chemotherapy who have newly diagnosed acute myeloid leukemia (AML) — a fast-growing blood cancer. The combinations all build on venetoclax plus azacitidine (the current standard), and test whether adding cladribine or chidamide (or alternating between them) improves outcomes. **You may be eligible if...** - You are 18 or older with a confirmed new diagnosis of AML - You are 60 or older, OR under 60 but not suitable for intensive chemotherapy, OR you refused intensive chemotherapy - You have adequate liver and kidney function - Your ECOG performance status is 2 or less (you can care for yourself) - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have previously received AML treatment (except emergency stabilization with hydroxyurea or a very small dose of cytarabine) - You have certain other prior cancers that are not in remission - You are pregnant or of childbearing potential and not using contraception - You have significant organ problems like severe liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVACl

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.

DRUGVACh

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

DRUGVACl 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

DRUGVA

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

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NCT06532552


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