Ruxolitinib + Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of different treatments for chronic myeloid leukemia (CML), a type of blood cancer. It examines tyrosine kinase inhibitors, which reduce cancer cells by blocking a necessary protein, and ruxolitinib, a drug that may further aid by blocking growth factors cancer cells use to expand. Participants will either continue their current treatment or add ruxolitinib to assess its additional benefits. This trial suits individuals who have maintained stable CML treatment for at least 12 months and whose CML has not worsened. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you continue taking your current tyrosine kinase inhibitor medication, such as bosutinib, nilotinib, dasatinib, or imatinib, for the duration of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ruxolitinib, when combined with other medications like dasatinib or nilotinib, is generally well-tolerated. Past studies found no unexpected safety issues with ruxolitinib. However, some patients experienced lower blood counts, including anemia (low red blood cells) and thrombocytopenia (low platelets), which are the most common side effects.
Dasatinib, nilotinib, and bosutinib are already used to treat chronic myeloid leukemia. These medications work by blocking a protein that aids cancer cell growth. They have been widely used and studied, and their safety is well understood.
Overall, while some side effects may occur, many patients find the treatments manageable. Prospective trial participants should discuss potential risks and benefits with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining ruxolitinib with tyrosine kinase inhibitors (TKIs) like dasatinib, nilotinib, and imatinib for chronic myeloid leukemia (CML) because of its unique approach. While TKIs are standard for CML, ruxolitinib introduces a new angle by targeting the JAK-STAT pathway, which could help overcome resistance and improve outcomes. This combination might offer enhanced effectiveness compared to traditional TKI treatments alone, potentially leading to better disease control and fewer side effects. By targeting multiple pathways simultaneously, the hope is to achieve a more comprehensive treatment response.
What evidence suggests that this trial's treatments could be effective for chronic myeloid leukemia?
Research has shown that certain drugs, known as tyrosine kinase inhibitors—such as bosutinib, dasatinib, nilotinib, and imatinib—effectively reduce cancer cells in people with chronic myeloid leukemia (CML). These drugs block a protein called BCR-ABL, which aids cancer cell growth. They are commonly used and have successfully treated CML by significantly lowering leukemia cell counts in the body. Participants in this trial may receive one of these tyrosine kinase inhibitors alone.
In another arm of this trial, participants will receive a combination of ruxolitinib and a tyrosine kinase inhibitor. Ruxolitinib targets the growth factors that CML cells need to survive. Early research suggests that adding ruxolitinib to tyrosine kinase inhibitors might better target the bone marrow, where these cancer cells grow, potentially enhancing treatment effectiveness. Although more research is needed, this combination shows promise for improving CML treatment outcomes.26789Who Is on the Research Team?
Kendra L Sweet
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitors (TKI) like bosutinib, dasatinib, imatinib or nilotinib for at least a year. They should have stable vital signs and organ function, not be pregnant or breastfeeding, agree to use contraception, and not have HIV with detectable viral loads. Prior cancer is okay if no active treatment is needed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a tyrosine kinase inhibitor alone or in combination with ruxolitinib for up to 12 months, with treatment cycles repeating every 90 days
Follow-up
Participants are monitored for safety, effectiveness, and survival outcomes after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Bosutinib
- Dasatinib
- Imatinib
- Nilotinib Hydrochloride Monohydrate
- Ruxolitinib Phosphate
Bosutinib is already approved in United States for the following indications:
- Treatment of adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy
- Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)
- Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML), newly-diagnosed or resistant or intolerant to prior therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator