CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 524 enrolled
Drug / intervention
rituximab +7 morebiological
Likely dose
R-CHOP or dose-adjusted EPOCH-R (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, etoposide, and growth factors)AI-extracted
Key inclusion· 7
  • Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease, or stage I primary mediastinal (thymic) DLBCL
  • WHO classification subtypes: DLBCL (centroblastic, immunoblastic, T-cell/histiocyte rich, anaplastic), mediastinal (thymic) large B-cell lymphoma, or intravascular large B-cell lymphoma
  • Fresh (frozen) tumor biopsy material available or attempted (minimum four 16-gauge needle cores or equivalent)
  • Age ≥18 years
Key exclusion· 6
  • Prior low-grade lymphoma, transformed lymphoma, or low-grade lymphoma in bone marrow
  • Prior cytotoxic chemotherapy or rituximab (unless prior limited field radiation or short glucocorticoid course <10 days for urgent local complications)
  • Chemotherapy for any prior malignancy
  • Known HIV infection

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

Search/NCT00118209
NCT00118209Phase 3Completed

Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 11, 2005·Updated Nov 17, 2021

In Brief

A Phase 3 clinical trial evaluating rituximab, cyclophosphamide, and 6 other interventions for Large B Cell Lymphoma. Completed, enrolled 524 participants across 47 sites.

Detailed Summary

This randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartMay 1, 2005
Primary CompletionOct 1, 2017
Study CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 21.0 years ago

Interventions

rituximabbiological

IV

cyclophosphamidedrug

IV

doxorubicindrug

IV or CIVI

vincristinedrug

IV or CIVI

prednisonedrug

oral

etoposidedrug

CIVI

filgrastimdrug

IV

pegfilgrastimdrug

IV