Phase II Study of Ibrutinib Plus FCR for Untreated Younger Patients with Chronic Lymphocytic Leukemia
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT02251548
This study is testing a new drug, ibrutinib, combined with standard chemotherapy drugs (FCR) to see if it is safe and effective for younger patients with Chronic Lymphocytic Leukemia (CLL) who have not received treatment before.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is exploring whether adding ibrutinib, a drug that blocks a protein helping CLL cells grow, to the standard chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) can improve treatment outcomes for patients with previously untreated CLL. Ibrutinib is already approved for CLL patients who have had prior treatments, but its use as a first treatment is still under investigation.
Description
Ibrutinib is a kinase inhibitor that targets Bruton's tyrosine kinase (BTK), a protein that helps CLL cells survive and grow. By blocking BTK, ibrutinib may kill cancer cells or stop them from growing. While ibrutinib is approved for CLL patients who have already been treated, it is still being studied as a first treatment option.
The standard treatment for younger CLL patients is a combination of chemotherapy drugs: fludarabine, cyclophosphamide, and rituximab (FCR). Although effective, FCR does not usually cure CLL. This study combines ibrutinib with FCR (iFCR) to see if this new combination is safe and effective for patients who have not been treated before.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma and need treatment based on specific criteria, such as worsening anemia or large lymph nodes.
- No previous CLL treatment.
- Age between 18 and 65 years.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood cell counts and organ function.
- Women and men must agree to use effective birth control during the study.
Exclusion Criteria
- History of other cancers unless treated and inactive for 3 years.
- Currently on immunosuppressant therapy or high-dose steroids.
- Recent live vaccine or infection requiring treatment.
- Known bleeding disorders or recent stroke.
- HIV, hepatitis B, or hepatitis C infections.
- Major surgery within 4 weeks.
- Serious heart conditions or gastrointestinal issues.
- Pregnant or breastfeeding women.
- Taking other study drugs or medications that interfere with the study.
- Unable to take preventive treatment for certain infections.
- Specific genetic markers that may affect treatment response.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | 33146 | Coral Gables | Florida |
| University of Miami Sylvester Comprehensive Cancer Center | 33442 | Deerfield Beach | Florida |
| Unversity of Miami Sylvester Comprehensve Cancer Center | 33136 | Miami | Florida |
| University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| West Michigan Cancer Center | 49007 | Kalamazoo | Michigan |
| Duke University Medical Center | 27710 | Durham | North Carolina |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.