NCT06660368

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Cladribine, 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.
DRUG	Venetoclax	Venetoclax will be administered orally, once daily, with food.

Timeline

• Start date: 2024-11-26
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-10-28
• Last updated: 2026-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study