Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01253070|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Results First Posted : February 11, 2016
Last Update Posted : November 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|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 Drug: Cytarabine Procedure: Bone Marrow Aspiration Procedure: Biopsy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 2|
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Primary Completion Date :||October 2014|
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 400mg 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 aspirateProcedure: Biopsy
Other Name: BxOther: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentOther: Questionnaire Administration
- Overall Survival (OS) Rate [ Time Frame: 1 year ]Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
- OS [ Time Frame: Time from registration to death (up to 10 years) ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253070
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|Principal Investigator:||Geoffrey Uy||Alliance for Clinical Trials in Oncology|