Last updated on August 2019

Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With Chronic Myeloid Leukemia


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib phosphate (ruxolitinib) plus a tyrosine-kinase inhibitor (TKI) (dasatinib or nilotinib) versus a TKI alone, based on local polymerase chain reaction (PCR) testing to measure BCR-ABL transcripts in chronic phase chronic myelogenous leukemia (CML) patients with molecular evidence of disease.

SECONDARY OBJECTIVES:

I. To estimate the frequency and severity of toxicities of each regimen in this patient population.

II. To estimate progression free survival and overall survival of each regimen in this patient population.

TERTIARY OBJECTIVES:

I. To describe patterns of MR4.5 and molecular rate 4.0 (MR4.0) attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population.

II. To evaluate drug compliance based on patient reported drug intake calendars in this patient population.

III. 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.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dasatinib orally (PO) daily or nilotinib PO twice daily (BID) on days 1-90. Treatment repeats every 90 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive ruxolitinib phosphate PO BID on days 1-90 and dasatinib PO daily or nilotinib PO BID on days 1-90. Treatment repeats every 90 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 5 years.

Clinical Study Identifier: NCT03654768

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Salt Lake City Veterans Affairs Medical Center

Salt Lake City, UT United States
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Huntsman Cancer Institute/University of Utah

Salt Lake City, UT United States
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