LAST: The Life After Stopping Tyrosine Kinase Inhibitors Study

Full Title

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST study)

Purpose

Imatinib, nilotinib, dasatinib, and bosutinib are drugs called "tyrosine kinase inhibitors" (TKI) which are used to treat chronic myelogenous leukemia (CML). Patients taking a TKI are instructed to continue taking it as long as they are responding to it and not having too many side effects. About half of patients who achieve deep remission, maintain it for a period of time, and stop taking the TKI continue to experience "treatment-free remission," but there is not enough evidence yet to make this standard practice.

In this study, researchers want to see how many patients can successfully have a treatment-free remission after stopping TKI treatment, and how many experience a return of their CML and need to restart treatment. Patients in remission will stop taking their TKI and then will be monitored to see whether or not the cancer comes back. Patient-reported outcomes (changes in symptoms or side effects) will be recorded regularly. The results of this study may improve the decision-making process between doctors and patients with CML who are considering stopping TKI therapy.

Eligibility

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

  • Patients must be taking imatinib, nilotinib, dasatinib, or bosutinib and must have been on TKI therapy for at least three years for CML.
  • Patients must have very low or undetectable BCR-ABL for at least two years.
  • Patients may not have developed resistance to TKI treatment.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Mauro at 212-639-3107.

Protocol

15-134

Phase

II

Investigator

Co-Investigators

Locations