drugset / Trial / NCT03904251

CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT03904251

NaSingle-groupOpen-labelTreatment

Summary

This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.

Timeline

Start
2019-07-18
Primary completion
2023-10-25
Completion
2023-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject CPX-351 Other / unclassified 44 mg/m2
Subject CPX-351 Other / unclassified 100 mg/m2
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2 Intravenous