Study on Adding Ruxolitinib to Usual Treatment for Chronic Myeloid Leukemia

Program Overview

This study is testing if combining ruxolitinib with standard drugs like bosutinib, dasatinib, imatinib, or nilotinib can better control chronic myeloid leukemia (CML). CML cells produce a protein called BCR-ABL that helps them grow. Tyrosine kinase inhibitors stop this protein, while ruxolitinib stops growth factors that CML cells need. The trial will see if this combination is more effective than the usual treatment alone.

Description

The main goal of this study is to compare how well the combination of ruxolitinib and a tyrosine kinase inhibitor (TKI) works in reducing leukemia cells compared to a TKI alone. Researchers will measure the response of the leukemia cells over 12 months using a specific test called PCR.

Secondary goals include checking the safety of the treatments, how long patients live without the disease getting worse, and overall survival rates. The study will also look at how patients respond to the treatment over time and how well they follow their medication schedule.

Participants will be randomly assigned to one of two groups:

• Group 1: Patients will take one of the standard TKIs (bosutinib, dasatinib, imatinib, or nilotinib) daily for 90 days, repeating this cycle up to four times unless the disease progresses or side effects become too severe.

• Group 2: Patients will take ruxolitinib twice daily along with one of the standard TKIs for 90 days, repeating this cycle up to four times unless the disease progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits every six months for two years, and then annually for up to five years.

Eligibility Criteria

Locations