CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
rituximab +6 morebiological
Likely dose
Cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab and bevacizumab; standard dose (specific doses not stated in interventions or arms)AI-extracted
Key inclusion· 8
  • Previously untreated Stage III, IV, or bulky Stage II diffuse large B-cell non-Hodgkin's lymphoma positive for CD20
  • Bidimensionally measurable disease documented within 28 days prior to registration
  • Bone marrow aspirate and biopsy performed within 42 days prior to registration
  • CT scan of chest/abdomen and pelvis within 28 days prior to registration
Key exclusion· 11
  • Prior chemotherapy, radiation, or antibody-based therapy for lymphoma
  • History of indolent lymphoma; histologic transformation or mixed histologies with indolent component
  • History of hypersensitivity to Polysorbate 20, Chinese hamster ovary cell products, or recombinant human antibodies
  • HIV-positive or history of solid organ transplantation

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

Search/NCT00121199
NCT00121199Phase 2Completed

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL

National Cancer Institute (NCI)·interventional·Posted Jul 21, 2005·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating rituximab, bevacizumab, and 5 other interventions for Contiguous Stage II Adult Diffuse Large Cell Lymphoma and 3 related conditions. Completed, enrolled 73 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.

Study Details

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2005
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.9 years ago

Interventions

rituximabbiological

Given IV

bevacizumabbiological

Given IV

cyclophosphamidedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

vincristine sulfatedrug

Given IV

prednisonedrug

Given PO

laboratory biomarker analysisother

Correlative studies