A Phase II Study to Determine if Patients with Chronic Myelogenous Leukemia Who Respond Well to Nilotinib Can Stop Taking this Drug

Protocol
13-111
Full Title
A Single-Arm, Multicenter, Nilotinib Treatment-Free Remission Study in Patients with BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment
Purpose

Studies have shown that some patients with chronic myelogenous leukemia (CML) who have responded well to the drug imatinib can stop taking the drug after they achieve a very low level of CML cells, and that nearly half of them do not experience a recurrence of their cancer even after being off imatinib for about three years. Among those who do have a recurrence, almost all who begin taking imatinib again respond to treatment.

Nilotinib is a drug for CML that works in a similar way as imatinib. The purpose of this study is to see if patients who achieve a very low level of CML cells with initial nilotinib treatment can stop taking nilotinib and maintain this low level of CML cells. Patients whose CML returns will begin taking nilotinib again, and researchers will examine their response to treatment. Investigators also want to survey patients about their side effects while on and off nilotinib treatment. Nilotinib is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have been taking nilotinib for at least two years to treat BCR-ABL-positive CML that was in chronic phase at the time of diagnosis.
  • Patients should have a very low level of CML cells.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ellin Berman at 212-639-7762.

Disease(s)
Leukemia: Chronic Myelocytic Leukemia
Locations
Related Diseases