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Clinical Trial 19737

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03654768

Phase: Phase II
Prinicipal Investigator: Kendra Sweet

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Overview

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.

Summary

This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Objective

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.

Treatments

Therapies

Medications

AMN107 (Nilotinib); Dasatinib (BMS-354825); Jakafi (Ruxolitinib); Nilotinib (); Ruxolitinib (); Tasigna (Nilotinib)

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 RT-PCR at a CLIA-approved laboratory and reported on the International Scale (IS) with a value of > 0.0032% IS and ≤ 1.0% IS within 21 days prior to randomization. The RTPCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from 100% IS (must be able to detect (0.0032% IS or lower).
  • Patients must have been on TKI therapy for CML for at least 12 months prior to randomization
  • Patients must be currently receiving treatment with bosutinib (within the allowable dose range of 200-500 mg daily), nilotinib (within the allowable dose range of 150 -400 mg BID or a cumulative daily dose of at least 300-800 mg), or dasatinib (within the allowable dose range of 40-140 mg daily). They must have received their current TKI for a minimum of 6 months prior to randomization and must be expected to remain on the same TKI for the next 12 months.
  • Patient must not have a history of resistance to any prior TKI drug. If patient has 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
  • Patients must not be receiving any other investigational agents.
  • Patients must have complete history and physical examination within 28 days prior to randomization
  • If clinically indicated, patients must have 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 on their most recent viral load test which must have been performed in the last 6 months.
  • 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 100% IS (must be able to detect 0.0032% IS or lower). Other eligibility criteria apply

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