Myeloproliferative Neoplasms Clinical Trial

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

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).

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Full Description

All participants will have a confirmed diagnosis of chronic phase chronic myeloid leukemia (CML) and must have previously attempted to discontinue TKI therapy. All participants must be restarted on a TKI at the time of relapse in order to be eligible for this trial.

After completion of 12 cycles of combination therapy, eligible participants will remain in the TFR phase of the study for up to 36 months, and will have central polymerase chain reaction (PCR) testing during the first 24 months. Therefore, the total duration of the trial will be approximately 48 months (12 months on combination treatment phase + 36 months in the TFR phase).

View Eligibility Criteria

Eligibility Criteria

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 to first TFR attempt, they should be on imatinib at time of enrollment on this study)
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
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
Must adhere to all study contraception guidelines

Exclusion Criteria:

History of accelerated or blast phase CML
History of TKI resistance
A second malignancy requiring active treatment
Have previously received treatment with a JAK inhibitor.
Platelet count less than 100 × 10^9/L or an absolute neutrophil count of less than 1 × 10^9/L or Hemoglobin less than 8 g/dL
AST and ALT ≥ 3 times the institutional upper limit of normal (ULN)
Creatinine ≥ 2 times ULN
Total bilirubin ≥ 1.5 times ULN or >3.0 x the ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)
Pregnant or lactating
Unable to comply with lab appointments schedule and patient response outcome assessments
Another investigational drug within 4 weeks of enrollment
Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol
Have undergone a prior allogeneic transplant
Screening 12-lead ECG showing a baseline corrected QT interval >500msec (patients with a pacemaker will still be eligible with QTc>500msec)

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT03610971

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There are 9 Locations for this study

See Locations Near You

H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Jhada-Kai Hunter
Contact
813-745-0286
[email protected]
Javier Pinilla-Ibarz, MD, PhD
Contact
813-745-4748
[email protected]
Javier Pinilla.Ibarz, MD, PhD
Principal Investigator
Emory -Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Rebecca Klisovic, MD
Contact
404-778-1900
[email protected]
Rebecca Klisovic, MD
Principal Investigator
Memorial Sloan Kettering - Bergen
Montvale New Jersey, 07645, United States More Info
Michael Mauro, MD
Contact
646-608-3744
[email protected]
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States More Info
James Thompson, MD
Contact
716-845-2300
[email protected]
James Thompson, MD
Principal Investigator
David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York New York, 10021, United States More Info
Michael Mauro, MD
Contact
646-608-3744
[email protected]
Duke University Hospital
Durham North Carolina, 27710, United States More Info
Quinna Lawson
Contact
919-668-2556
[email protected]
Lindsey Rein, MD
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States More Info
Michael Heinrich, MD
Contact
503-494-1080
[email protected]
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Ehab Atallah, MD
Contact
414-805-4600
[email protected]
Ehab Atallah, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT03610971

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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