CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Rituximabdrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age ≥ 3 years
  • ✓Biopsy-confirmed lymphocyte-predominant Hodgkin's disease of B-cell lineage with CD20 antigen expression
  • ✓Biopsy-confirmed expression of CD20 antigen
  • ✓At least one tumor mass > 1.0 cm in largest dimension
Key exclusion· 7
  • ✕Evidence of other active malignancies (except cured cervical carcinoma in situ or basal cell carcinoma of skin)
  • ✕Active HBV infection or hepatitis
  • ✕Serious non-malignant disease (e.g., congestive heart failure, active uncontrolled infections)
  • ✕Concurrent or recent (within 4–6 weeks) chemotherapy or radiotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003820
NCT00003820Phase 2Completed
CompareCT.gov

Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Ranjana Advani·interventional·Posted Jan 27, 2003·Updated Apr 20, 2017

In Brief

A Phase 2 clinical trial evaluating Rituximab for Lymphoma and 2 related conditions. Completed, enrolled 39 participants across 2 sites.

Detailed Summary

Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Hodgkin Lymphoma (Category), Nodular Lymphocyte Predominant Hodgkin Lymphoma
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJan 1, 1999
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 23.4 years ago

Interventions

Rituximabdrug

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.