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

Plain-language summary

This study evaluates the drug Sorafenib Tosylate combined with chemotherapy in older patients with Acute Myeloid Leukemia (AML). It included patients with a confirmed AML diagnosis by WHO criteria (excluding certain subtypes). It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

National Cancer Institute (NCI)

Intervention

Biopsy, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Sorafenib Tosylate

Start date

4/1/2011

Estimated completion

4/15/2021

Countries

United States

Related genes

Locations

• Lewes, United States
• Newark, United States
• Orlando, United States
• Chicago, United States
• Evanston, United States
• Fort Wayne, United States
• Iowa City, United States
• Augusta, United States
• Bangor, United States
• Baltimore, United States
• Elkton, United States
• Boston, United States
• Boston, United States
• Boston, United States
• Battle Creek, United States
• Big Rapids, United States
• Grand Rapids, United States
• Grand Rapids, United States
• Grand Rapids, United States
• Muskegon, United States
• Reed City, United States
• Traverse City, United States
• Columbia, United States
• St Louis, United States
• Lebanon, United States
• Camden, United States
• Lake Success, United States
• Lake Success, United States
• Manhasset, United States
• New Hyde Park, United States
• New York, United States
• Syracuse, United States
• Goldsboro, United States
• Kinston, United States
• Winston-Salem, United States
• Columbus, United States
• Norman, United States
• Oklahoma City, United States
• Pittsburgh, United States
• Charleston, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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)