SWOG clinical trial number
S1712
A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease
Closed
Phase
Accrual
96%
Abbreviated Title
Rando PhII Ruxolitinib + BCR-ABL TKIs in CML w/Molecular Disease
Status Notes
The study is closed to accrual effective 10/20/2022.
Activated
07/20/2018
Research committees
Leukemia
Treatment
Dasatinib
Ruxolitinib
Nilotinib
bosutinib
Eligibility Criteria Expand/Collapse
Patients must:
Have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML;
Have detectable BCR-ABL transcripts reported on the International Scale (IS) with a value of > 0.0032% IS and </= 1.0% IS within 21 days prior to randomization;
Be receiving treatment with dasatinib (within the allowable dose range of 40-140 mg daily) or nilotinib (within the allowable dose range of 150-400 mg BID) or bosutinib (within the allowable dose range of 200-500 mg daily) as first or second line therapy for a minimum of 6 months prior to registration;
Not have a history of resistance to any prior TKI drug. If patient received more than one TKI, the reason for changing treatment must have been intolerance to the prior TKI and the treatment change must have occurred >/= 6 months prior to randomization;
Be >/= 18 years of age;
Have complete history and physical exam within 28 days prior to randomization;
If clinically indicated, have QTcF interval < 500 ms (by Fridericia calculation) on EKG within 7 days prior to randomization;
Have platelet value >/= 100,000/mm3, ANC > 1,000/mm3, hemoglobin >/= 8g/dL, AST and ALT </= 2.5 x IULN, total bilirubin </= 1.5 x IULN and serum creatinine </= 1.5 x IULN within 7 days prior to randomization;
Not be pregnant or nursing;
Sign and give written informed consent to participate in this investigational trial.
Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.
Patients known to be HIV-positive are eligible provided they meet all other eligibility criteria and have undetectable HIV viral loads within the past 6 months.
Specimens (peripheral blood) must be collected and submitted to a CLIA-approved lab within 21 days prior to randomization.
Patients must be offered participation in specimen banking for future research.
Have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML;
Have detectable BCR-ABL transcripts reported on the International Scale (IS) with a value of > 0.0032% IS and </= 1.0% IS within 21 days prior to randomization;
Be receiving treatment with dasatinib (within the allowable dose range of 40-140 mg daily) or nilotinib (within the allowable dose range of 150-400 mg BID) or bosutinib (within the allowable dose range of 200-500 mg daily) as first or second line therapy for a minimum of 6 months prior to registration;
Not have a history of resistance to any prior TKI drug. If patient received more than one TKI, the reason for changing treatment must have been intolerance to the prior TKI and the treatment change must have occurred >/= 6 months prior to randomization;
Be >/= 18 years of age;
Have complete history and physical exam within 28 days prior to randomization;
If clinically indicated, have QTcF interval < 500 ms (by Fridericia calculation) on EKG within 7 days prior to randomization;
Have platelet value >/= 100,000/mm3, ANC > 1,000/mm3, hemoglobin >/= 8g/dL, AST and ALT </= 2.5 x IULN, total bilirubin </= 1.5 x IULN and serum creatinine </= 1.5 x IULN within 7 days prior to randomization;
Not be pregnant or nursing;
Sign and give written informed consent to participate in this investigational trial.
Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.
Patients known to be HIV-positive are eligible provided they meet all other eligibility criteria and have undetectable HIV viral loads within the past 6 months.
Specimens (peripheral blood) must be collected and submitted to a CLIA-approved lab within 21 days prior to randomization.
Patients must be offered participation in specimen banking for future research.
Publication Information Expand/Collapse
2024
A randomized trial of the addition of ruxolitinib to BCR::ABL1 tyrosine kinase inhibitors (TKIs) for patients with chronic myeloid leukemia (CML) with molecular evidence of disease (SWOG trial S1712)
A Randomized Trial of the Addition of Ruxolitinib to BCR::ABL Tyrosine Kinase Inhibitors for Patients with Chronic Myeloid Leukemia with Molecular Evidence of Disease (SWOG Trial S1712)
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