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Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated February 18, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Enrollment target: 30 to 100
    • Site contacts updated at 1 of 3 sites
    v4
  3. Interventions: CALGE-VEN- RIC-MBF (Drug) to CALGE-VEN- RIC-conditioning (Drug)
    • Study description expanded, about 13 words
    • Study title shortened, about 1 word
    v3
  4. Primary endpoint revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 8 words
    • Study title expanded, about 4 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (CLAGE) as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia (AML). In this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of CLAGE; 2) Reduced intensity conditioning (RIC) regimen as fludarabine, busulfan and melphalan (MBF) or total marrow irradiation (TMI); 3) Venetoclax was added to the chemotherapy and conditioning regimen.
Trial Details
NCT Number NCT05870995
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Refractory Leukemia
Related terms Leukemia, Leukemia, Myeloid, Acute
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov