CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Rituximab 375 mg/m2drug
Likely dose
Rituximab 375 mg/m²AI-extracted
Key inclusion· 5
  • B-cell non-Hodgkin's lymphoma with CD20+ expression
  • Evidence of engraftment following autologous peripheral blood stem cell transplant (ASCT)
  • ECOG performance status 0 to 1
  • Adequate renal function: creatinine < 2 mg/dL
Key exclusion· 9
  • Graft source from bone marrow (must be peripheral blood stem cells)
  • Prior non-response or disease progression with anti-CD20 therapy
  • Progressive disease after ASCT
  • Post-ASCT radiotherapy

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

Search/NCT00225212
NCT00225212Phase 2Completed

Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma

Stanford University·interventional·Posted Sep 23, 2005·Updated Sep 15, 2014

In Brief

A Phase 2 clinical trial evaluating Rituximab 375 mg/m2 for Non-Hodgkin's Lymphoma and 5 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy. Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartNov 1, 1997
Primary CompletionMar 1, 2003
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

Rituximab 375 mg/m2drug