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BCL2i CLAG-M in R/R Acute Myeloid Leukemia

StatusRecruiting
PhasePhase 2
Started2024-11-26
View on ClinicalTrials.gov ↗

Amendment history

2026-03-31
3 amendments v4-v6
3 re-verifications since 2025-10-01, no change to tracked fields
2025-06-17
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 2 sites
2025-03-14
Study Status v2
Re-verified, no change to tracked fields
2024-12-17
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2024-11-26
Study sitesdetails revised at 2 of 2 sites
2024-10-24
Original filing
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 Number NCT06660368
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: AbbVie
Conditions Relapsed or Refractory Acute Myeloid Leukemia (AML)
Enrollment 52 participants
Start Date 2024-11-26
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-01