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An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01833039
Enrollment
Unknown
Registered
2013-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Mantle Cell Lymphoma

Keywords

Mantle Cell Lymphoma, Ibrutinib

Brief summary

The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.

Interventions

DRUGIbrutinib

Ibrutinib

Sponsors

Pharmacyclics LLC.
CollaboratorINDUSTRY
Janssen Biotech, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.

Exclusion criteria

* Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible. * Patients previously treated with ibrutinib are not eligible. * Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.

Countries

Brazil, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026