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Approved for marketingNCT01833039Updated Feb 3, 2025

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

An expanded access record providing Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma, sponsored by Janssen Biotech, Inc.. Approved for marketing at 51 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Janssen Biotech, Inc. · Expanded access

Study type
Expanded access
Access type
Treatment IND/protocol
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed or Refractory Mantle Cell Lymphoma

Keywords

  • Mantle Cell Lymphoma
  • Ibrutinib
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

Janssen Biotech, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Access details

Study type
Expanded access
Access type
Treatment IND/protocol

Available treatment

  • DrugIbrutinib

    Ibrutinib

06

Where to request access

51 sites
  • Phoenix, Arizona, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Stanford, California, United States
  • Denver, Colorado, United States
  • Norwalk, Connecticut, United States
  • Stamford, Connecticut, United States
  • Washington, District of Columbia, United States
  • Miami Beach, Florida, United States
  • Ocala, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Springfield, Illinois, United States
  • Goshen, Indiana, United States
  • Sioux City, Iowa, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • Metairie, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • Jefferson City, Missouri, United States
  • Saint Louis, Missouri, United States
  • Lincoln, Nebraska, United States
  • Omaha, Nebraska, United States
  • Reno, Nevada, United States
  • Hackensack, New Jersey, United States
  • New Hyde Park, New York, United States
  • New York, New York, United States
  • Syracuse, New York, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Watertown, South Dakota, United States
  • Knoxville, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Burlington, Vermont, United States
  • Morgantown, West Virginia, United States
  • Barretos, Brazil
  • Florianopolis, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Salvador, Brazil
  • Sao Paulo, Brazil
  • San Juan, Puerto Rico
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01833039
Lead sponsor
Janssen Biotech, Inc.
Collaborators
Pharmacyclics LLC.
Responsible party
Sponsor
First posted
Apr 16, 2013
Last update
Feb 3, 2025
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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