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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Not applicable to Phase 2v2 Show 5 more changesShow less
    • Enrollment target: 20 to 72
    • Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT06621212
Lead Sponsor First Affiliated Hospital of Zhejiang University
Collaborators: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions
(from sponsor)		 Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy
Related terms Leukemia, Myeloid, Acute
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov