BCL2i CLAG-M in R/R Acute Myeloid Leukemia

This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.

Trial Details

NCT ID
NCT06660368
Phase
PHASE2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
  • Venetoclax
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Provision of signed and dated informed consent form.
  • Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
  • Adults aged ≥18 years - 80 years.
  • Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., \<5% blasts in BM or blood) with…

For full eligibility, visit ClinicalTrials.gov.

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