A Study to See if Ruxolitinib plus TKI Therapy Can Help Patients with Chronic Myeloid Leukemia Stop Treatment a Second Time

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Full Title

Treatment Free Remission After Combination Therapy with Ruxolitinib Plus Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Purpose

Patients with chronic myeloid leukemia (CML) take medications called tyrosine kinase inhibitors (TKIs), such as imatinib, dasatinib, nilotinib, and bosutinib. Once treated long enough and if in a deep, steady remission, the goal is to stop taking these medications and maintain the remission. However, sometimes the cancer comes back. Giving more treatment at this point is highly successful, but little is known about trying to stop treatment a second time.

Because of the increasing number of people in remission who may not have been successful in stopping TKI therapy the first time, studies have begun to determine how to improve the chance of achieving a second treatment-free remission. In people with CML, the drug ruxolitinib has been studied in combination with TKIs and was shown to be safe and effective in improving a response. The purpose of this study is to determine if adding ruxolitinib to TKI therapy for a period of time before a second attempt at stopping could improve the chance of maintaining remission without treatment.

Ruxolitinib is already used to treat other blood disorders; its use in this study is considered investigational. It 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 CML, achieved remission, attempted stopping TKIs once, experienced a relapse, and be back on TKI treatment and in remission.
  • 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 646-608-3744.

Protocol

19-442

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators