Study Comparing Ibrutinib and Rituximab with Fludarabine, Cyclophosphamide, and Rituximab for Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02048813
This clinical trial is comparing two treatment options for patients with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It aims to find out which combination of drugs is more effective in stopping cancer growth and improving patient outcomes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing two different treatment combinations for patients with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). One group will receive ibrutinib and rituximab, while the other group will receive fludarabine, cyclophosphamide, and rituximab. The goal is to see which treatment works better in stopping cancer growth and improving survival rates. Ibrutinib works by blocking enzymes that help cancer cells grow, while rituximab helps the immune system target cancer cells. Fludarabine and cyclophosphamide are chemotherapy drugs that kill cancer cells or stop them from spreading.
Description
The main goal of this study is to see if the combination of ibrutinib and rituximab can help patients live longer without their cancer getting worse, compared to the standard treatment of fludarabine, cyclophosphamide, and rituximab (FCR). Researchers will also look at overall survival rates, side effects, and quality of life for patients on both treatments.
Patients will be randomly assigned to one of two groups. Group A will take ibrutinib daily and receive rituximab starting in the second cycle. This treatment will last for up to 10 years if there are no serious side effects or disease progression. Group B will receive rituximab, fludarabine, and cyclophosphamide in cycles, with treatment lasting for 6 cycles unless there are serious side effects.
The study will also explore how different factors, like genetic markers and immune function, affect treatment outcomes. Patients will be followed for up to 10 years after treatment to monitor their health and any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on specific medical criteria.
- No previous treatment for CLL or SLL.
- Must have certain symptoms or disease progression that requires treatment, such as worsening anemia or enlarged lymph nodes.
- Aged between 18 and 70 years.
- Good overall health with an ECOG performance status of 0 to 2.
- Life expectancy of at least 12 months.
- Able to tolerate FCR-based therapy.
- No specific genetic deletion (17p13) that affects treatment response.
- Adequate kidney and liver function based on specific blood tests.
- No active hemolytic anemia requiring treatment.
- Not currently using corticosteroids, except for low doses for non-cancer conditions.
- No other active cancer requiring treatment.
- Able to follow study procedures and attend visits.
- No major surgery within the last 4 weeks or minor surgery within 3 days before starting the study.
- No recent radiation therapy.
- HIV-positive patients may be eligible if they meet specific criteria, such as controlled viral load.
- No serious heart conditions or recent infections.
- Not taking certain medications that interact with the study drugs.
- Women must not be pregnant or breastfeeding and must use effective contraception.
- Able to swallow capsules and have no significant gastrointestinal issues.
- No recent live vaccines or bleeding disorders.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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