CALGB 10801: Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Study Status

Open to Enrollment

Study Description

CALGB 10801: A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib and Continuation Therapy with Dasatinib Alone in Newly Diagnosed Patients with Core Binding Factor Acute Myeloid Leukemia (AML)

This is a clinical trial for patients with acute myeloid leukemia (AML) that possesses an abnormal molecular feature (a gene mutation). The purpose of this study is to test the safety and effectiveness of adding the drug dasatinib to a treatment regimen in patients with AML and to determine how well the leukemia responds to the treatment. The study is being done because currently available treatment is not effective in curing patients with this type of leukemia.

There are three parts to the treatment in this study. The first part of the therapy will test the safety and effectiveness of adding dasatinib to the standard combination of chemotherapy drugs used to treat AML that include daunorubicin and cytarabine. The second part of the therapy will test the safety and effectiveness of combining dasatinib with another chemotherapy treatment, consolidation therapy with high-dose cytarabine. Finally, the third part of the therapy will test the effectiveness of the use of dasatinib alone for 12 months during continuation therapy.

Patients will receive therapy for about 18 months on study. After you are finished with the therapy, you will be asked to visit the office for follow-up at least every 2 months for 2 years, then every 3 months for 2 years, then yearly for a maximum of 10 years from when you entered the study.

Disease Status and/or Stage

Acute Myeloid Leukemia (AML) with Core Binding Factor Abnormaility

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 and older
  • Acute myeloid leukemia (AML with Core Binding Factor (CBF) abnormality
  • No prior chemotherapy for leukemia or myelodysplasia
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

Protocol ID

CALGB 10801

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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]

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