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

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 ce

Trial Details

NCT ID
NCT06532552
Phase
PHASE2
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • VACl
  • VACh
  • VACl Alternating With VACh
  • VA
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
  • Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a stan…
  • Subject must be≥18 years of age with at least one of the following conditions:
  • A)≥60 years of age; B) Patients aged \< 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges …

For full eligibility, visit ClinicalTrials.gov.

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