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Clinical Trial Summary

This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus allow for the deepest and most durable response possible in patients with CML in chronic phase who have achieved a complete hematologic remission (CHR), complete cytogenetic remission (CCyR), and major molecular remission (MMR), but not a complete molecular remission (CMR). The study will look at safety and tolerability of ruxolitinib when combined with nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose) of ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is established in the phase I setting, a phase II evaluation will seek to establish the efficacy of this combination.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02973711
Study type Interventional
Source University of Michigan Rogel Cancer Center
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date January 2018
Completion date August 2021

See also
  Status Clinical Trial Phase
Completed NCT04384848 - The EMPATHY Pilot Study N/A
Recruiting NCT03515018 - Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients Phase 3
Active, not recruiting NCT02381379 - Malaysia Stop Tyrosine Kinase Inhibitor Trial Phase 3
Active, not recruiting NCT02852486 - Study of Imatinib Discontinuation in Chronic Myeloid Leukemia With Deep Molecular Response Phase 2
Recruiting NCT02326311 - Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response Phase 3
Terminated NCT02627573 - Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT Phase 2
Terminated NCT01761695 - Chronic Myelod Leukemia Registry at Asan Medical Center
Not yet recruiting NCT02389920 - Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib Phase 4