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Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01724346 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2024-09-19

Study results available
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Summary

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Conditions

Interventions

DRUG

Ibrutinib

Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

DRUG

Next-line ibrutinib

Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-03
Primary Completion
2023-08-18
Completion
2023-08-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Ireland
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT01724346 on ClinicalTrials.gov