CALGB 11001: A Phase II Study Incorporating Sorafenib Into The Therapy of Patients ≥ 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia
Study Status
Open to Enrollment
Study Description
Approximately 25% of patients with acute myeloid leukemia (AML) have a mutation in the leukemia cells in a gene called FLT3. This mutation may help leukemia cells grow and survive. The experimental drug sorafenib blocks the effects of this abnormal FLT3 gene. Combining sorafenib with a standard chemotherapy regimen may be more effective than treatment with the standard chemotherapy regimen alone.he purpose of this clinical trial is to study the effects of combining the drugs daunorubicin and cytarabine, a standard AML therapy, with sorafenib in patients with acute myeloid leukemia who are age 60 and older.
The purpose of this clinical trial is to study the effects of combining the drugs daunorubicin and cytarabine, a standard AML therapy, with sorafenib in patients with acute myeloid leukemia who are age 60 and older.
There will be three parts to the treatment in this study:
1. Remission Induction Therapy (patients will be hospitalized for this part of the treatment)
- Cytarabine by IV infusion for 7 days
- Daunorubicin once a day for 3 days
- Oral sorafenib twice daily for 7 days
2. Remission Consolidation Therapy
- Intermediate-dose cytarabine (higher dose than in Part 1) IV infusion over 3 hours for 5 days
- Oral sorafenib twice daily for 28 days
3. Maintenance Therapy
- Sorafenib twice daily for 28 days
- Up to 12 courses of sorafenib
Patients will receive treatment in the study for approximately 1 year and 3 months. The study physician may recommend additional treatment after that, or possibly a bone marrow transplant instead of continued treatment on study. After completing study treatment patients will be asked to return for long-term follow-up.
Disease Status and/or Stage
FLT3 Mutated Acute Myeloid Leukemia
Sponsor
CALGB
Key Eligibility
- Men and women age 60 and older
- Acute Myeloid Leukemia (AML) with FLT3 mutation
- No prior chemotherapy for AML except for:
- Emergency leukapheresis
- Emergency treatment for hyperluekocytosis with hydroxyurea
- Cranial radiotherapy for CNS leukostasis (one dose only)
- Growth factor/cytokine support
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Tania Curcio, RN
- (212) 746-2571
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
