Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
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|ClinicalTrials.gov Identifier: NCT03610971|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Phase Chronic Myeloid Leukemia Chronic Myeloid Leukemia, Chronic Phase||Drug: Ruxolitinib Drug: BCR-ABL Tyrosine Kinase Inhibitor (TKI)||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Combination Therapy + Remission Phase
Combination therapy followed by treatment free remission (TFR) phase.
Combination Therapy: Ruxolitinib plus BCR-ABL Tyrosine Kinase Inhibitors (TKIs).
All eligible patients will begin ruxolitinib in combination with their BCR-ABL TKI on cycle 1 day 1 of the combination phase. They will continue combination therapy for a total of 12 cycles. Each cycle will be 28 days. At the end of 12 cycles ruxolitinib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, participants will discontinue their BCR-ABL TKI and be monitored off treatment.
Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
Other Name: Jakafi®
Drug: BCR-ABL Tyrosine Kinase Inhibitor (TKI)
The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.
Other Name: TKI
- 12 Month Treatment Free Remission (TFR) [ Time Frame: 12 months ]TFR rate after completion of 12 cycles of combination therapy.
- Adverse Events Possibly Related to Study Treatment [ Time Frame: Up to 30 days post treatment, approximately 13 months per participant ]Establish the adverse event profile of ruxolitinib in combination with BCR-ABL TKIs: Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0, that are possibly, probably, or definitely related to study treatment.
- Incidence of Improved Scores in Health Related Quality of Life Questionnaire [ Time Frame: Up to 48 months ]Number of participants with an improved score in 2 or more categories of the questionnaire at the end of the TFR phase, when compared to the score for the same questions when completed at the end of 12 cycles of combination therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610971
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Anthony McLaughlin 813-745-5941 firstname.lastname@example.org|
|Contact: Kendra Sweet, M.D. 813-745-8986 email@example.com|
|Principal Investigator: Kendra Sweet, M.D.|
|United States, Wisconsin|
|Froedtert Hospital & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Ehab Atallah, MD 414-805-4600 firstname.lastname@example.org|
|Principal Investigator: Ehab Atallah, MD|
|Principal Investigator:||Kendra Sweet, M.D.||H. Lee Moffitt Cancer Center and Research Institute|