Clinical Trial: NCT02160015
Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-08-21 |
Study Overview
Brief Summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (relapsed), has not responded well to prior treatments (refractory), has spread to other parts of the body (metastatic), or cannot be removed by surgery. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide together with ibrutinib and rituximab may kill more cancer cells.
Official Title
Conditions
Intervention / Treatment
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Biopsy
- Procedure: Computed Tomography
- Procedure: Electrocardiogram
- Drug: Ibrutinib
- Drug: Lenalidomide
- Procedure: Magnetic Resonance Imaging
- Biological: Rituximab
Other Study ID Numbers
- NCI-2014-01157
- NCI-2014-01157
- 2015-00531
- 2013-1342
- 9540
- 9540
- P30CA051008
- 2015
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: | 2026-08-21 |
Study Overview
Brief Summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (relapsed), has not responded well to prior treatments (refractory), has spread to other parts of the body (metastatic), or cannot be removed by surgery. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide together with ibrutinib and rituximab may kill more cancer cells.
Official Title
Conditions
Intervention / Treatment
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Biopsy
- Procedure: Computed Tomography
- Procedure: Electrocardiogram
- Drug: Ibrutinib
- Drug: Lenalidomide
- Procedure: Magnetic Resonance Imaging
- Biological: Rituximab
Other Study ID Numbers
- NCI-2014-01157
- NCI-2014-01157
- 2015-00531
- 2013-1342
- 9540
- 9540
- P30CA051008
- 2015