NCT03878927

CPX-351+GO in Subjects 55 Years Old, or Older, With AML

Phase I Trial, With an Expansion Cohort, of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Combination With Gemtuzumab in Subjects With Acute Myeloid Leukemia >55 Years of Age Who Have Not Been Treated With Intensive Chemotherapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study to assess the safety and efficacy of CPX-351 in combination with gemtuzumab ozogamicin (GO) as first intensive therapy in older (age \>55 years) subjects with newly diagnosed AML who are eligible for intensive induction chemotherapy, or AML subjects who previously failed low-intensity therapy but who would be eligible for high-intensity chemotherapy, with companion cognitive function testing to determine whether this contributes to outcome in these subjects. Subjects may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low-dose cytarabine, or lenalidomide or a clinical trial drug in combination with hypomethylating agents or low-dose cytarabine, but may not have received intensive AML treatment with anthracyclines and/or infusional cytarabine prior to enrollment on this trial. Subjects may not have been treated with GO or other antibody targeting CD 33 prior to enrollment on this trial. The cohort will include 30 subjects treated with the combination of CPX-351 and GO and is designed to establish the safety and feasibility of the combination. These subjects will be assessed for efficacy and safety. Quality of life will be assessed using the FACT-LEU in all subjects. Cognitive function will be assessed using the Blessed Orientation-Memory-Concentration Test and the Montreal Cognitive Assessment.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CPX-351	CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio.
DRUG	Gemtuzumab Ozogamicin	Gemtuzumab ozogamicin is a CD-33 directed antibody drug conjugated to calicheamicin. CD 33 is expressed on myeloid leukemic blast cells and on normal hematopoietic cells. The drug is approved for the treatment of newly diagnosed CD 33 positive AML in adults and the treatment of relapsed and refractory CD 33 positive AML in adults. The drug is available for injection 4.5 mg as a lyophilized cake or powder in a single use vial for reconstitution and dilution.

Timeline

• Start date: 2019-08-23
• Primary completion: 2022-08-15
• Completion: 2022-09-01
• First posted: 2019-03-18
• Last updated: 2023-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study