OncRef

Clinical Trial: NCT01722487

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Pharmacyclics LLC.
Information Provided By:Pharmacyclics LLC.
Last Update Posted:2017-11-30

Study Overview

Brief Summary

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Official Title

Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Ibrutinib
  • Drug: Chlorambucil

Other Study ID Numbers

  • PCYC-1115-CA
  • 2012-003967-23

Start Date

2013-03

Primary Completion Date (Actual)

2015-05

Study Completion Date (Actual)

2015-05

Enrollment (Actual)

269

Study Type

Interventional

Phase

Phase 3