Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01253070|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Results First Posted : February 11, 2016
Last Update Posted : May 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Acute Myeloid Leukemia (Megakaryoblastic) With t(1;22)(p13.3;q13.3); RBM15-MKL1 Acute Myeloid Leukemia With a Variant RARA Translocation Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2) or t(3;3) (q21.3;q26.2); GATA2, MECOM Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214 Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Acute Myeloid Leukemia With Variant MLL Translocations Untreated Adult Acute Myeloid Leukemia||Procedure: Biopsy Procedure: Bone Marrow Aspiration Drug: Cytarabine Drug: Daunorubicin Hydrochloride Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Sorafenib Tosylate||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|
|Actual Study Start Date :||April 1, 2011|
|Actual Primary Completion Date :||October 31, 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 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.
Other Name: BxProcedure: Bone Marrow Aspiration
Undergo bone marrow aspirateDrug: Cytarabine
Other Names:Drug: Daunorubicin Hydrochloride
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentOther: Questionnaire Administration
Ancillary studiesDrug: Sorafenib Tosylate
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|