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CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients
Sponsor: Fred Hutchinson Cancer Center
Summary
This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, cladribine, cytarabine, G-CSF, and mitoxantrone, 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 CPX-351 or the CLAG-M regimen at doses typically used for medically-fit patients with acute myeloid leukemia may work better than reduced doses of CPX-351 in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms.
Official title: Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-03-11
Completion Date
2027-12-31
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
Cladribine
Given IV
Cytarabine
Given IV
Recombinant Granulocyte Colony-Stimulating Factor
Given SC
Mitoxantrone
Given IV
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States