drugset / Trial / NCT04196010

Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms

NCT04196010

Phase 1 Terminated 13 enrolled University of Washington
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of a chemotherapy regimen given by continuous intravenous infusion (CI-CLAM), and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory) or other high-grade myeloid neoplasms. Drugs used in CI-CLAM include cladribine, cytarabine and mitoxantrone, and 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. Continuous intravenous infusion involves giving drugs over a time duration of equal to or more than 24 hours. Giving CLAM via continuous infusion may result in fewer side effects and have similar effectiveness when compared to giving CLAM over the shorter standard amount of time.

Timeline

Start
2020-05-08
Primary completion
2021-10-13
Completion
2021-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cladribine Small molecule Intravenous
Subject Cytarabine Small molecule Intravenous
Subject Mitoxantrone Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous