BCL2i CLAG-M in R/R Acute Myeloid Leukemia (NCT06660368)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (16 items).
Location: Moffitt Cancer Center — Tampa, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Venetoclax-refractory disease or recent venetoclax exposure \< 3 months prior to first dose of study therapy.
- Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.).
- Allogeneic stem cell transplant in the past 3 months.
- Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.
- Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility).
- Active CNS involvement by AML.
- WBC count ≥25k at the time study treatment begins.
- Uncontrolled intercurrent systemic illness that would limit compliance.
- Concurrent malignancy in addition to AML that requires active treatment with some exceptions.
- Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg/day or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD).
- Participants who have not recovered from adverse events (Aes) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), with the exception of alopecia.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Moffitt Cancer Center — Tampa, Florida
- Dana-Farber Cancer Institute — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.