Status:
COMPLETED
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia With FLT3/ITD Mutation
Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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 bl...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if the 1-year overall survival rate of patients age \>= 60 with FLT3-ITD AML treated with a sorafenib (sorafenib tosylate) containing induction and post-remission ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01253070
Start Date
April 1 2011
End Date
April 15 2021
Last Update
August 4 2022
Active Locations (43)
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1
Beebe Medical Center
Lewes, Delaware, United States, 19958
2
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637