Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors (NCT03610971)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Willing and able to give informed consent
2. 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.
3. Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician
4. Must have met ALL the following criteria prior to first attempt to discontinue their TKI:
5. 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.
6. 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
7. Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
8. 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
9. 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
10. 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 to first TFR attempt, they should be on imatinib at time of enrollment on this study)
11. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
12. Must have a RQ-PCR for BCR-ABL less than 0.0032% IS (MR4.5) reported by the trial designated central lab at time of study enrollment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
• Emory -Winship Cancer Institute — Atlanta, Georgia
• Memorial Sloan Kettering - Bergen — Montvale, New Jersey
• Roswell Park Comprehensive Cancer Center — Buffalo, New York
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering — New York, New York
• Duke University Hospital — Durham, North Carolina
• Oregon Health & Science University — Portland, Oregon
• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.