Study on Treatment-Free Remission After Combining Ruxolitinib with Tyrosine Kinase Inhibitors

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03610971

Provider View

This clinical trial is exploring whether adding Ruxolitinib to a Tyrosine Kinase Inhibitor (TKI) can help patients with chronic myeloid leukemia (CML) stay in remission longer after stopping TKI treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if combining Ruxolitinib with a Tyrosine Kinase Inhibitor (TKI) can help patients with chronic phase chronic myeloid leukemia (CML) maintain remission without ongoing treatment. Participants will first receive 12 cycles of the combination therapy. If eligible, they will then enter a treatment-free remission (TFR) phase for up to 36 months, during which they will undergo regular testing. The entire study will last about 48 months.

Description

Participants in this study must have chronic phase chronic myeloid leukemia (CML) and have previously tried to stop taking a Tyrosine Kinase Inhibitor (TKI) but had to restart it due to a relapse. The study involves taking a combination of Ruxolitinib and a TKI for 12 months. After this, eligible participants will enter a phase where they try to stay in remission without treatment for up to 36 months. During this time, they will have regular tests to monitor their condition. The total duration of the study is approximately 48 months, including both the treatment and remission phases.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent.
  • Diagnosed with chronic phase chronic myeloid leukemia (CML) with specific genetic markers (b3a2 or b2a2 variants).
  • Previously tried to stop TKI treatment once under a doctor's guidance.
  • Had a stable molecular response for over 2 years before first stopping TKI, with specific test results.
  • Treated with an FDA-approved TKI (imatinib, dasatinib, nilotinib, or bosutinib) for at least 3 years before stopping.
  • Relapsed after first attempt to stop TKI, with specific test results showing loss of major molecular response.
  • Must have been back on a TKI for at least 1 year after relapse and plan to continue the same TKI during the study.
  • Current TKI must be the same as the one used before the first remission attempt.
  • ECOG performance status between 0 and 3.
  • Specific test results showing low levels of BCR-ABL at study enrollment.
  • Must follow study contraception guidelines.

Exclusion Criteria

  • History of advanced phases of CML.
  • History of resistance to TKI treatment.
  • Another active cancer requiring treatment.
  • Previous treatment with a JAK inhibitor.
  • Low blood cell counts or hemoglobin levels.
  • High liver enzyme levels (AST and ALT).
  • High creatinine or bilirubin levels, unless due to Gilbert Syndrome.
  • Pregnant or breastfeeding.
  • Unable to attend lab appointments or follow study procedures.
  • Recent use of another investigational drug.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Previous allogeneic transplant.
  • Abnormal heart rhythm on an ECG test, unless due to a pacemaker.

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