OncRef

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 RECRUITING

Phase:

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

A Phase 1 Study of Lenalidomide and Ibrutinib in Combination With Rituximab in Relapsed and Refractory CLL and SLL

Conditions

Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma

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)

2014-05-20

Primary Completion Date (Actual)

2017-03-27

Study Completion Date (Estimated)

2027-08-19

Enrollment (Actual)

12

Study Type

Interventional

Phase

Phase 1