New Clinical Trial: Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

The Weill Cornell Leukemia Program is now recruiting patients for a new study, “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).”

The physician leading the study at Weill Cornell is Gail Roboz, MD. For more information or to see if you are eligible for the study, please contact Tania Curcio, RN at (212) 746-2571 or email Tania at tjc9003@med.cornell.edu.

Study details:

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.

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