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

Leukemia, Chronic Myeloid Clinical Trial

Official title:
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Status Withdrawn

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

Leukemia, Chronic Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase

Clinical Trial Details

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Status	Withdrawn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

View Details

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