NCT03610971

Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors

Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).

Detailed description

All participants will have a confirmed diagnosis of chronic phase chronic myeloid leukemia (CML) and must have previously attempted to discontinue TKI therapy. All participants must be restarted on a TKI at the time of relapse in order to be eligible for this trial. After completion of 12 cycles of combination therapy, eligible participants will remain in the TFR phase of the study for up to 36 months, and will have central polymerase chain reaction (PCR) testing during the first 24 months. Therefore, the total duration of the trial will be approximately 48 months (12 months on combination treatment phase + 36 months in the TFR phase).

Conditions

• Chronic Phase Chronic Myeloid Leukemia
• Chronic Myeloid Leukemia, Chronic Phase

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
DRUG	BCR-ABL Tyrosine Kinase Inhibitor (TKI)	The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.

Timeline

• Start date: 2019-11-19
• Primary completion: 2025-09-25
• Completion: 2026-10-01
• First posted: 2018-08-01
• Last updated: 2026-04-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study