Clinical Trial: NCT02048813
Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-08-28 |
Study Overview
Brief Summary
This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Official Title
Conditions
Intervention / Treatment
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- Drug: Ibrutinib
- Other: Laboratory Biomarker Analysis
- Other: Pharmacogenomic Study
- Other: Quality-of-Life Assessment
- Biological: Rituximab
Other Study ID Numbers
- NCI-2014-00118
- NCI-2014-00118
- E1912
- ECOG-E1912
- E1912
- E1912
- R01CA193541
- U10CA021115
- U10CA180820
- U24CA196172
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-08-28 |
Study Overview
Brief Summary
This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Official Title
Conditions
Intervention / Treatment
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- Drug: Ibrutinib
- Other: Laboratory Biomarker Analysis
- Other: Pharmacogenomic Study
- Other: Quality-of-Life Assessment
- Biological: Rituximab
Other Study ID Numbers
- NCI-2014-00118
- NCI-2014-00118
- E1912
- ECOG-E1912
- E1912
- E1912
- R01CA193541
- U10CA021115
- U10CA180820
- U24CA196172