Phase IB/II of CPX-351 for Relapse Prevention in AML
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior allogeneic transplant
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
Acute promyelocytic leukemia [t(15;17)]
If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness
Trial design
Treatments tested in this trial
- CPX-351
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Georgetown University
Lead sponsor
Jazz Pharmaceuticals
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov