A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission,…
Interventions
- DrugCladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
Filgrastim/G-CSF 300 mcg/day for 6 days beginning 24 hours prior to multiagent chemotherapy (days 0-5), cladribine 5 mg/m2 given intravenously over 2 hours for 5 consecutive days (days 1-5), cytarabine given IV over 4 hours for 5 consecutive days (days 1-5) beginning 2 hours after the completion of cladribine, and mitoxantrone 16 mg/m2 given intravenously over 30 minutes for 3 days (days 1-3) after completion of cytarabine.
- DrugVenetoclax
Venetoclax will be administered orally, once daily, with food.
Locations (2)
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts