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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: December 2, 2010
Last updated: November 14, 2016
Last verified: November 2016
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.

Condition Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 54
Study Start Date: April 2011
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given IV
Other Names:
  • DNM
  • DNR
  • DRB
Drug: Sorafenib Tosylate
Given PO
Other Names:
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: Cytarabine
Given IV
Other Names:
  • CHX-3311
  • U-19920
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspirate
Procedure: Biopsy
Undergo biopsy
Other Name: Bx
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

  Show Detailed Description


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Cancer and Leukemia Group B (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01253070

  Show 43 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Geoffrey Uy Alliance for Clinical Trials in Oncology
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01253070     History of Changes
Other Study ID Numbers: NCI-2011-02618
NCI-2011-02618 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB 11001 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-11001 ( Other Identifier: CTEP )
U10CA180821 ( US NIH Grant/Contract Award Number )
U10CA031946 ( US NIH Grant/Contract Award Number )
Study First Received: December 2, 2010
Results First Received: January 13, 2016
Last Updated: November 14, 2016

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on April 21, 2017