NCT01702064

Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

A Phase I Study of Ruxolitinib in Combination With Nilotinib in CML Patients With Evidence of Molecular Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination with nilotinib in patients with chronic myeloid leukemia (CML).

Conditions

• Chronic Phase Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Nilotinib	Participants will remain on the same dose of nilotinib they have been receiving prior to enrollment on the trial. This will range from 300 mg PO BID to 400 mg PO BID. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose of ruxolitinib, based on the number of dose.
DRUG	Ruxolitinib	Dose escalation will follow a 3+3 study design. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose, based on the number of dose limiting toxicities seen at a specific dose.

Timeline

• Start date: 2013-02-21
• Primary completion: 2016-10-17
• Completion: 2019-01-09
• First posted: 2012-10-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: United States