Ruxolitinib and Tyrosine Kinase Inhibitors for the Treatment of Recurrent Chronic Phase-Chronic Myeloid Leukemia

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT03610971
Trial Phases:	Phase II	Protocol IDs:	MCC-19660 (primary) NCI-2019-08022 HJKC3-0002
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Moffitt Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03610971

Summary

This phase II trial studies how well ruxolitinib and tyrosine kinase inhibitors (TKIs), including imatinib, dasatinib, nilotinib or bosutinib, work in treating patients who are attempting to stop TKI medications for a second time for chronic phase-chronic myeloid leukemia that has come back (recurrent). Ruxolitinib and imatinib, dasatinib, nilotinib or bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to see if adding ruxolitinib to imatinib, dasatinib, nilotinib or bosutinib works better in prolonging treatment-free remission in patients with chronic phase-chronic myeloid leukemia.

Objectives

PRIMARY OBJECTIVE:
I. To determine the 1-year treatment free remission rate after 12 cycles of combination therapy with TKIs plus ruxolitinib phosphate (ruxolitinib) in subjects who have experienced molecular relapse after prior TKI discontinuation.

SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of the treatment combinations.
II. To assess the impact on health-related quality of life in patients while on combination therapy and after TKI discontinuation.
III. To compare changes in phosphorylation of STAT3 (pSTAT3) in K562 and KU812 cell lines measured by the Phos-Flow (STAT3/5) platform, using plasma from chronic myeloid leukemia (CML) patients being treated with TKIs plus ruxolitinib using the plasma inhibitory assay technique.
IV. To describe multiparameter flow based assessment of the T-cell compartment (activity/polarization) as well as natural killer (NK) cells in CML patients at various time points when they are being treated with TKIs alone, TKIs plus ruxolitinib and at a time when they are off both TKIs and ruxolitinib.
V. To correlate changes in pSTAT3 and pSTAT5 with clinical response and rate of treatment free remission (TFR).

OUTLINE:

COMBINATION TREATMENT PHASE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) and imatinib, dasatinib, nilotinib or bosutinib on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

TREATMENT FREE REMISSION PHASE: Patients undergo collection of blood samples at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 58, 64, 70, 76, 82, 88, 94, and 100. Patients whose results show they are no longer in major molecular response (MMR) resume treatment with imatinib, dasatinib, nilotinib or bosutinib per physician discretion.

After completion of study treatment, patients are followed up every 6 months until 5 years from study entry.

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