Phase IB/II of CPX-351 for Relapse Prevention in AML (NCT04990102) | Clinical Trial Compass
RecruitingPhase 1/2
Phase IB/II of CPX-351 for Relapse Prevention in AML
United States24 participantsStarted 2023-05-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed patients \> 18 years of age
* Patients must be in CR or CRh (complete remission with partial count recovery).
* 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.
* Must be able to start therapy within 3 months of last documented CR
* De novo or secondary AML/treatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed
* Patients must be ineligible for allogeneic BMT (for any reason including poor performance status, patient's preference, favorable AML not a candidate for transplant, or comorbidities and age precluding from transplant etc)
* 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)
* Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 is permissible if due to disease.
* 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) (See Appendix A)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 (Appendix A)
* Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 …
What they're measuring
1
Maximum tolerate dose (Phase 1)
Timeframe: 1 cycle (28 day cycle)
2
Inicidence of Treatment Emergent Adverse events (Phase 2)