Relapsed or Refractory Mantle Cell LymphomaNCT01833039
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
A study testing Ibrutinib in people with Relapsed or Refractory Mantle Cell Lymphoma, run by Janssen Biotech, Inc. at 51 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Mantle Cell Lymphoma
- What is being tested?
- Ibrutinib
- How many people
- Not given
- Where
- 51 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.
Who cannot join
- 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.
Trial locations and contacts
51 sites in 3 countries.
51 sites in 3 countries
United States44 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Burlington, Vermont
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Goshen, Indiana
Study site
Hackensack, New Jersey
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Jefferson City, Missouri
Study site
Knoxville, Tennessee
Study site
Lexington, Kentucky
Study site
Lincoln, Nebraska
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Metairie, Louisiana
Study site
Miami Beach, Florida
Study site
Morgantown, West Virginia
Study site
New Hyde Park, New York
Study site
New York, New York
Study site
Norwalk, Connecticut
Study site
Ocala, Florida
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Reno, Nevada
Study site
Rochester, Minnesota
Study site
Sioux City, Iowa
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
Stamford, Connecticut
Study site
Stanford, California
Study site
Syracuse, New York
Study site
Washington D.C., District of Columbia
Study site
Watertown, South Dakota
Study site
Worcester, Massachusetts
Brazil6 sites
Study site
Barretos
Study site
Florianópolis
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo
About this study
Official title: An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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.
- Being tested
- Ibrutinib
- Keywords
- Mantle Cell Lymphoma, Ibrutinib
- Medical subject headings
- Recurrence, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Ibrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833039
- Sponsor's protocol ID
- CR101862
- Other IDs
- PCI-32765MCL4001
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2013
- Last updated
- 3 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01833039
- Acronym / sponsor ID
- CR101862
- Keywords
- Mantle Cell Lymphoma, Ibrutinib
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pharmacyclics LLC.
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibIbrutinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell LymphomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibrutinib in people with Relapsed or Refractory Mantle Cell Lymphoma, run by Janssen Biotech, Inc. at 51 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Brazil, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.