Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML

The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.

Trial Details

NCT ID
NCT06621212
Phase
PHASE2
Sponsor
First Affiliated Hospital of Zhejiang University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • mitoxantrone hydrochloride liposome
  • Cytarabine
  • Venetoclax
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study an…
  • Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
  • Patients who failed after at least 1 courses of initial induction therapy.
  • Bone marrow blasts≥5% after CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leuke…

For full eligibility, visit ClinicalTrials.gov.

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