Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

Inclusion Criteria:

• Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days prior to enrollment)

• Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications

• Able to give written informed consent and comply with all study visits and procedures

Exclusion Criteria:

• Chronic myeloid leukemia (CML) in AP or BP

• Unable to receive TKI for insurance reasons (uninsurable)

• Refuse or unable to perform telephone or video conferences with research coordinator

• Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI

• Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject