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A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT02264574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2020-09-21

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

Conditions

Interventions

DRUG

Ibrutinib

Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.

DRUG

Obinutuzumab

Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration

DRUG

Chlorambucil

Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration

Sponsors & Collaborators

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • Lori Styles · Pharmacyclics LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2018-03-26
Completion
2019-09-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Russia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264574 on ClinicalTrials.gov