Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Acute Promyelocytic Leukemia With PML-RARA, FLT3 Gene Mutation, Therapy-Related Acute Myeloid Leukemia

In brief

This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.

Key facts

Study ID

NCT01253070

Run by

National Cancer Institute (NCI)

People needed

54

Starts

2011-04-01

Expected to finish

2021-04-15

Last updated by the study team

2022-08-04

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unequivocal histologic diagnosis of AML according to World Health Organization (WHO) criteria, EXCLUDING:
• Acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (PML)-retinoic acid receptor, alpha (RARA)
• Acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (RUNX1-RUNXT1) as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per CALGB 20202
• Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22); core-binding factor, beta subunit (CBFB)-myosin, heavy chain 11, smooth muscle (MYH11) as determined by the OSU Molecular Reference Laboratory, per CALGB 20202
• AML patients with an antecedent hematologic disorder are eligible for treatment on this trial provided that they have not received chemotherapy, including lenalidomide, azacitidine or decitabine for their hematologic disorder; patients with therapy-related AML are eligible if there had been no further exposure to chemotherapy or radiation therapy for > 3 years and their primary malignancy is in remission
• FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202
• No prior chemotherapy for AML with the following exceptions:
• Emergency leukapheresis
• Emergency treatment for hyperleukocytosis with hydroxyurea
• Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
• Growth factor/cytokine support
• All-trans retinoic acid (ATRA)

Where it is running

• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• AdventHealth Orlando — Orlando, Florida, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Harold Alfond Center for Cancer Care — Augusta, Maine, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Christiana Care - Union Hospital — Elkton, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Bronson Battle Creek — Battle Creek, Michigan, United States
• Spectrum Health Big Rapids Hospital — Big Rapids, Michigan, United States
• Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Mercy Health Mercy Campus — Muskegon, Michigan, United States
• Spectrum Health Reed City Hospital — Reed City, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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