OncoMatch/Clinical Trials/NCT04990102
Phase IB/II of CPX-351 for Relapse Prevention in AML
Is NCT04990102 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CPX-351 for acute myeloid leukemia (aml) in remission.
Treatment: CPX-351 — This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Disease stage
Required: Stage CR, CRH
Patients must be in CR or CRh (complete remission with partial count recovery)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax
Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than 12 cycles of treatment
Cannot have received: allogeneic transplant
Prior allogeneic transplant
Cannot have received: anthracycline (doxorubicin)
Previous cumulative anthracycline (doxorubicin equivalent) dose equal to or greater than 345 mg/m2, and for patients with prior mediastinal XRT, anthracycline dose equal to or greater than 295 mg/m2
Lab requirements
Kidney function
Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault based on actual weight)
Liver function
Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN); Bilirubin ≤3 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Cardiac function
Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan
Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan; Adequate hepatic and renal function defined as: Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN); Bilirubin ≤3 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault based on actual weight)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
- John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey
- University of Pennsylvania · Philadelphia, Pennsylvania
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