OncRef

Clinical Trial: NCT02629809

Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With 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:2026-09-16

Study Overview

Brief Summary

This phase II trial studies how well ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab together may work better in treating chronic lymphocytic leukemia.

Official Title

First-Line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) With Mutated IGHV Gene and Non-Del(17p)

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Cyclophosphamide
  • Drug: Fludarabine Phosphate
  • Drug: Ibrutinib
  • Biological: Obinutuzumab

Other Study ID Numbers

  • 2015-0281
  • NCI-2016-00016
  • 2015-0281

Start Date (Actual)

2016-03-18

Primary Completion Date (Estimated)

2028-03-31

Study Completion Date (Estimated)

2028-03-31

Enrollment (Actual)

81

Study Type

Interventional

Phase

Phase 2