Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=54 Treatment

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

Acute Myeloid Leukemia With FLT3/ITD Mutation · Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 · Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 · Acute Promyelocytic Leukemia With PML-RARA · FLT3 Gene Mutation

Bottom Line

View on ClinicalTrials.gov: NCT01253070 ↗
Enrolled (actual)
54
Serious AEs
42.0%
Results posted
Feb 2016
Primary outcome: Primary: Overall Survival (OS) Rate — 62; 71 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Biopsy (Procedure); Bone Marrow Aspiration (Procedure); Cytarabine (Drug); Daunorubicin Hydrochloride (Drug); Laboratory Biomarker Analysis (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Sorafenib Tosylate (Drug)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival (OS) Rate		 62; 71 —
SECONDARY
OS		 15; 16.2 —
SECONDARY
Event-free Survival		 8.8; 7.8 —

Summary

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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01253070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search