Relapsed or Refractory Mantle Cell Lymphoma Clinical Trial
Official title:
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
| NCT number | NCT01833039 |
| Other study ID # | CR101862 |
| Secondary ID | PCI-32765MCL4001 |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | October 2018 |
| Source | Janssen Biotech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Biotech, Inc. | Pharmacyclics LLC. |
United States, Brazil, Puerto Rico,