Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia

This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. The primary objective is to assess the rate of MRD (Minimal Residual Disease) negativity and the duration of MRD-negative status following treatment. Secondary objectives include evaluating overall response rate (CR/CRi), overall survival, progression-free survival, and safety. Treatment consists of induction therapy with Bugitinib and Venetoclax orally for 28 days combined with

Trial Details

NCT ID
NCT07563179
Phase
PHASE2
Sponsor
Shenzhen University General Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Bugitinib
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Participants must meet all of the following criteria:
  • Age 18-70 years (inclusive), regardless of sex;
  • Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions:
  • Failure to achieve complete remission (CR) after standard induction chemotherapy;

For full eligibility, visit ClinicalTrials.gov.

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