CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
filgrastim +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00911183
NCT00911183Phase 2Completed

Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life

Institut Bergonié·interventional·Posted Jun 1, 2009·Updated Aug 29, 2025

In Brief

A Phase 2 clinical trial evaluating filgrastim, pegfilgrastim, and 5 other interventions for Lymphoma. Completed, enrolled 67 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma. PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesFrance

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2009
Enrollment StartDec 2, 2008
Primary CompletionDec 31, 2012
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.1 years ago

Interventions

filgrastimbiological

Given subcutaneously

pegfilgrastimbiological

Given subcutaneously

rituximabbiological

Given IV

cyclophosphamidedrug

Given IV

liposome-encapsulated doxorubicin citratedrug

Given IV

prednisonedrug

Given orally

vincristine sulfatedrug

Given IV