Relapsed NLPHL Clinical Trial
Official title:
Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
| Verified date | October 2015 |
| Source | University of Cologne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Interventional |
The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | September 2015 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - relapsed nodular lymphocyte predominant hodgkin lymphoma - age 18 - 75 - review of diagnosis by experienced pathologist - no major organ dysfunction Exclusion Criteria: - classical hodgkin lymphoma - CD20 antibody treatment within the last 6 months prior enrollment - chronic or current infectious disease requirering systemic antibiotics - other past or current malignancy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | 1st Department of Medicine, Cologne University Hospital | Cologne |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cologne |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate | 12 months after end of treatment | No | |
| Secondary | duration of response | 12 months after end of treatment | No | |
| Secondary | Progression free survival | 12 months after end of treatment | No | |
| Secondary | adverse events | 12 months after end of treatment | Yes |