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Clinical Trial 19737

Cancer Type: Malignant Hematology
Interventions:AMN107 (Nilotinib); Dasatinib (BMS-354825); Jakafi (Ruxolitinib); Nilotinib; Ruxolitinib; Tasigna (Nilotinib)

Study Type: Treatment
Phase of Study: Phase II

  • Kendra Sweet

Call 813-745-6100
or 1-800-679-0775

Study Title

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.- Study Chairs: Kendra Sweet, M.D., Jerald P. Radich, M.D.



Primary Objective a. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib plus a TKI (dasatinib or nilotinib) versus a TKI alone, based on local PCR testing to measure BCR-ABL transcripts in chronic phase CML patients with molecular evidence of disease Secondary Objectives a. To estimate the frequency and severity of toxicities of each regimen in this patient population. b. To estimate progression free survival and overall survival of each regimen in this patient population. Additional Objectives a. To describe patterns of MR4.5 and MR4.0 attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population. b. To evaluate drug compliance based on patient reported drug intake calendars in this patient population. c. To describe the kinetics of response in this patient population (as measured by quantitative BCR-ABL/BCR ratio) in both arms over the 3, 6, 9, and 12-month time points.

Inclusion Criteria

  • Patients must have a diagnosis of chronic phase chronic myeloid leukemia (CML) without any history of progression to accelerated or blast phase CML; no new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required
  • Patients must have detectable BCR-ABL transcripts measured by reverse transcriptase (RT)-PCR at a clinical laboratory improvement act (CLIA)-approved laboratory and reported on the international scale (IS) with a value of > 0.0032% IS and => Patients must 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
  • Patients must not have received > 2 TKIs for treatment of CML (hydroxyurea prior to initiation of TKI is allowed). Patients must have been on their current TKI for a minimum of 6 months prior to randomization. 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)
  • Patients must have been receiving TKI treatment for CML for at least one year and no more than 10 years prior to randomization
  • Patients must be expected to remain on the same TKI for the next 12 months
  • Patients must not be receiving any other investigational agents
  • Patients must have complete history and physical examination within 28 days prior to randomization
  • Patients must have corrected Fridericia's correction formula (QTcF) interval > Platelets >= 100,000/mm^3 (100.0 x 10^9/L) within 7 days prior to randomization
  • Absolute neutrophil count (ANC) > 1,000/mm^3 (1.0 x 10^9/L) within 7 days prior to randomization
  • Hemoglobin >= 8 g/dL within 7 days prior to randomization
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) => Total bilirubin => Serum creatinine => Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed
  • Patients must not be pregnant or nursing; women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization; women/men of reproductive potential must have agreed to use an effective contraceptive method during treatment and for 30 days after discontinuation of study drug.
  • Patients known to be human immunodeficiency virus positive (HIV+) are eligible provided they meet all other eligibility criteria and have undetectable HIV viral loads
  • Specimens (peripheral blood) must be collected and submitted to a CLIA-approved laboratory, within 21 days prior to randomization; BCR-ABL transcripts must be measured using RT-PCR and results must be reported using the international scale; the RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from baseline (at least 0.0032% IS)
  • Other criteria may apply