drugset / Trial / NCT03724084

Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement

NCT03724084

Phase 1/2 Terminated 6 enrolled National Cancer Institute (NCI)
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called MLL gene rearrangement. Pinometostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in standard chemotherapy, such as daunorubicin hydrochloride and cytarabine, work 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. Giving pinometostat with standard chemotherapy may work better at treating acute myeloid leukemia.

Timeline

Start
2019-04-10
Primary completion
2022-11-14
Completion
2022-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Pinometostat Small molecule Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous