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Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

NCT02437019 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2017-03-20

No results posted yet for this study

Summary

The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.

Conditions

  • B-cell Chronic Lymphocytic Leukemia

Interventions

DRUG

PCI-32765 (Ibrutinib)

Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle.

Sponsors & Collaborators

  • Janssen-Cilag Farmaceutica Ltda.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial · Janssen-Cilag Farmaceutica Ltda.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil

Study Locations

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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 NCT02437019 on ClinicalTrials.gov