Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
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.
Acute Myeloid Leukemia (Megakaryoblastic) With t(1;22)(p13;q13); RBM15-MKL1
Acute Myeloid Leukemia With a Variant RARA Translocation
Acute Myeloid Leukemia With Inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
Acute Myeloid Leukemia With t(6;9)(p23;q34); DEK-NUP214
Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Acute Myeloid Leukemia With Variant MLL Translocations
Untreated Adult Acute Myeloid Leukemia
Drug: Daunorubicin Hydrochloride
Drug: Sorafenib Tosylate
Procedure: Bone Marrow Aspiration
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients ≥ 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia|
- Overall survival (OS) rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Percentage of patients who were alive at 1 year. The 1-year OS was estimated using the Kaplan Meier method.
- OS [ Time Frame: Time from registration to death (up to 10 years) ] [ Designated as safety issue: No ]OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
- Event-free survival [ Time Frame: Time from registration to death or relapse (up to 10 years) ] [ Designated as safety issue: No ]Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.
|Study Start Date:||April 2011|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (daunorubicin, cytarabine, sorafenib tosylate)
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
Drug: Daunorubicin Hydrochloride
Other Names:Drug: Sorafenib Tosylate
Other Names:Drug: Cytarabine
Other Names:Procedure: Bone Marrow Aspiration
Undergo bone marrow aspirate
Other Name: Bone Marrow AspirationProcedure: Biopsy
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentOther: Questionnaire Administration
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01253070
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|Principal Investigator:||Geoffrey Uy||Alliance for Clinical Trials in Oncology|