NCT02973711

A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

A Phase I/II Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML Who Have Achieved a Complete Hematologic Remission, Complete Cytogenetic Remission, and Major Molecular Remission, But Not a Complete Molecular Remission on a Tyrosine Kinase Inhibitor Alone.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Chronic Myeloid

Interventions

Type	Name	Description
DRUG	Nilotinib	Nilotinib 300 mg BID
DRUG	Ruxolitinib	Ruxolitinib, 10, 15 or 20mg BID

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2016-11-25
• Last updated: 2021-02-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study