Trials / Completed
CompletedNCT00003820
Rituximab in Treating Patients With Hodgkin's Lymphoma
Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Ranjana Advani · Academic / Other
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
Detailed description
This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months. This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders. |
Timeline
- Start date
- 1999-01-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2003-01-27
- Last updated
- 2017-04-20
- Results posted
- 2017-04-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00003820. Inclusion in this directory is not an endorsement.