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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
CPX-351
DrugDaunorubicin 8.8mg/m2 + cytarabine 20mg/m2
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: CPX-351Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerate dose (Phase 1)
Number of subjects with Dose Limiting toxicities will be used to determine the recommended phase II dose of CPX-351 to be used in the maintenance setting for newly diagnosed AML in complete remission.
Time frame
1 cycle (28 day cycle)2
Inicidence of Treatment Emergent Adverse events (Phase 2)
To determine the safety, tolerability and toxicity of CPX-351 in the maintenance setting for newly diagnosed AML in complete remission by analyzing the incidence of treatment emergent adverse events reported.
Time frame
6 cycles (28 day cycles)Secondary outcomes
1
Incidence of Treatment Emergent Adverse Events (Phase 1)
To determine the safety, tolerability and toxicity of CPX-351 in the maintenance setting for newly diagnosed AML in complete remission by analyzing the incidence of treatment emergent adverse events reported.
Time frame
6 cycles (28 day Cycle)2
Overall Survival (Phase 1 and 2)
Determine the efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by overall survival of subjects.
Time frame
1 year after end of treatment3
Event free survival (Phase 1 and 2)
Determine efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by event free survival.
Time frame
1 year after end of treatment4
Relapse Free Survival (Phase 1 and 2)
Determine efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by relapse free survival.
Time frame
1 year after end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgetown University
Lead sponsor
Jazz Pharmaceuticals
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov