Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors (NCT03610971) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
United States24 participantsStarted 2019-11-19
Plain-language summary
The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to give informed consent
* Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein.
* Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician
* Must have met ALL the following criteria prior to first attempt to discontinue their TKI:
* Stable molecular response (MR4; \<0.01% IS) for \> 2 years (allowance for a 2 week variance), as documented on at least 4 tests, performed at least 3 months apart. If any results are \>0.05% IS, tests must have been repeated within 1 month and be less than 0.01% IS and stable.
* Treatment with one of the following FDA approved TKI; imatinib, dasatinib, nilotinib or bosutinib, at any dose for a minimum of approximately 3 years (allowance of a 4 week variance) prior to discontinuing TKIs
* Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
* Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR-ABL \> 0.1% IS after first attempted discontinuation of TKI
* After first failed TFR attempt, must have a minimum duration of 1 year on a TKI, and must plan to remain on this same TKI for a minimum of 12 months during the combination treatment phase
* Current TKI must be the same as the TKI being taken prior to the initial TFR attempt (e.g., if patient is on imatinib prior…
What they're measuring
1
12 Month Treatment Free Remission (TFR)
Timeframe: 12 months post 12 cycles of treatment
Trial details
NCT IDNCT03610971
SponsorH. Lee Moffitt Cancer Center and Research Institute