Ibrutinib + FCR for Chronic Lymphocytic Leukemia
(iFCR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of medications, including ibrutinib, to determine its effectiveness in treating Chronic Lymphocytic Leukemia (CLL). Ibrutinib, a type of targeted therapy, will be used alongside standard drugs fludarabine, cyclophosphamide, and rituximab. The goal is to assess whether this combination is more effective than the standard treatment alone. The trial seeks participants diagnosed with CLL who experience symptoms like severe fatigue or night sweats and have not received previous treatment for CLL. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain immunosuppressants, warfarin, or strong CYP3A inhibitors or inducers. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining ibrutinib with fludarabine, cyclophosphamide, and rituximab (FCR) is generally safe. In earlier studies, patients who took ibrutinib and rituximab experienced fewer serious side effects than those who only received the standard FCR treatment.
Early results suggest that ibrutinib with FCR is usually well-tolerated. Most side effects are manageable and similar to those from standard treatments. Common side effects include mild nausea, tiredness, and low blood cell counts, which are typical in cancer treatments and can often be managed with additional care.
These findings are promising for those considering joining the trial, as the treatments have been tested for safety and many patients have tolerated them well. However, discussing personal health and potential risks with a healthcare provider before participating is important.12345Why do researchers think this study treatment might be promising for CLL?
Researchers are excited about the combination treatment of Ibrutinib with FCR (Fludarabine, Cyclophosphamide, and Rituximab) for Chronic Lymphocytic Leukemia because it offers a new mechanism of action. Ibrutinib works by inhibiting Bruton's tyrosine kinase, an enzyme crucial for the survival and proliferation of leukemia cells, which is different from traditional chemotherapy approaches that broadly target rapidly dividing cells. This targeted approach has the potential to improve efficacy and reduce side effects compared to conventional treatments like chemotherapy alone. Additionally, the oral administration of Ibrutinib provides greater convenience for patients compared to intravenous therapies. Researchers are hopeful that this combination will lead to better outcomes for patients.
What evidence suggests that ibrutinib in combination with FCR could be an effective treatment for Chronic Lymphocytic Leukemia?
This trial will evaluate the combination of Ibrutinib with FCR (Fludarabine, Cyclophosphamide, and Rituximab) for treating Chronic Lymphocytic Leukemia (CLL). Studies have shown that combining Ibrutinib with Rituximab helps people with CLL live longer without disease progression compared to traditional treatments like FCR. Research indicates that this combination is effective for patients, regardless of specific gene mutations. Additionally, studies on combining Ibrutinib with FCR show promise in treating CLL. This treatment stops cancer cells from growing and surviving, which may explain its effectiveness. Overall, evidence supports optimism for Ibrutinib's role in improving CLL treatment.34678
Who Is on the Research Team?
Matthew S. Davids
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults aged 18-65 with confirmed chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment based on specific criteria like worsening anemia, significant weight loss, fatigue, fevers without infection, and night sweats. They should not have had previous CLL therapy and must be able to perform daily activities (ECOG ≤1). Adequate blood counts and liver/renal function are required. Participants must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib in combination with fludarabine, cyclophosphamide, and rituximab (FCR) for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bone marrow biopsies and PET CT scans
Ibrutinib Maintenance
Participants continue with ibrutinib maintenance therapy to assess long-term response
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- Ibrutinib
- Rituximab
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Pharmacyclics LLC.
Industry Sponsor
Dr. Maky Zanganeh
Pharmacyclics LLC.
Chief Executive Officer
Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France
Dr. Ellie Im
Pharmacyclics LLC.
Chief Medical Officer
MD from an unspecified institution
The Leukemia and Lymphoma Society
Collaborator
Blood Cancer Research Partnership
Collaborator