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A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

NCT01744691 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2017-02-27

Study results available
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Summary

An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion

Conditions

  • Chronic Lymphocytic Leukemia With 17p Deletion
  • Small Lymphocytic Lymphoma With 17p Deletion

Interventions

DRUG

Ibrutinib

All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • Alvina Chu, MD · Pharmacyclics LLC.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-06-30
Completion
2016-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • New Zealand
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01744691 on ClinicalTrials.gov