OncRef

Clinical Trial: NCT02007044

Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-06-22

Study Overview

Brief Summary

This phase II trial studies ibrutinib with or without rituximab in treating patients with chronic lymphocytic leukemia that has come back after treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether ibrutinib is more effective with or without rituximab in treating chronic lymphocytic leukemia.

Official Title

Ibrutinib vs Ibrutinib + Rituximab (i vs iR) in Patients With Relapsed (CLL)

Conditions

Prolymphocytic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Ibrutinib
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Biological: Rituximab

Other Study ID Numbers

  • 2013-0703
  • NCI-2014-00989
  • NCI-2014-00843
  • 2013-0703

Start Date (Actual)

2013-12-06

Primary Completion Date (Estimated)

2028-06-30

Study Completion Date (Estimated)

2028-06-30

Enrollment (Actual)

66

Study Type

Interventional

Phase

Phase 2