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

Open
Phase
II
Accrual
2%
Abbreviated Title
Rando PhII Ruxolitinib + BCR-ABL TKIs in CML w/Molecular Disease
Status Notes
The study is open to accrual effective 7/20/18.
Activated
07/20/2018

Research committees

Leukemia

Treatment

Dasatinib Ruxolitinib Nilotinib

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 70-100 mg daily) or nilotinib (within the allowable dose range of 200-400 mg BID) as first or second line therapy for a minimum of 6 months prior to registration.
NOTE: If dasatinib or nilotinib is second-line therapy, the reason for stopping first-line treatment must not have been resistance to prior treatment or failure to achieve an adequate response on their first-line TKI (e.g., the patient could have stopped due to intolerance to prior TKI).
Not have received > 2 TKIs for treatment of CML (hydroxyurea prior to initiation of TKI is allowed) and have been on their current TKI for a minimum of 6 months prior to randomization;
Have been receiving TKI treatment for CML for at least one year and no more than 10 years prior to randomization and must be expected to remain on the same TKI for the next 12 months;
Be >/= 18 years of age
Have complete history and physical exam within 28 days prior to randomization;
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.
Patients must be offered participation in specimen banking for future research

Reports & Approvals

Trial Locations

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Research Committee(s)
Leukemia
Activated
02/08/1971
Closed
Phase
I
SWOG Clinical Trial Number
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ROAP-AdOAP in Acute Adult Leukemia

Research Committee(s)
Leukemia
Activated
08/04/1978
Closed
09/10/1982
Closed
Phase
III
Published