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Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial

NCT00911183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-08-29

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

filgrastim

Given subcutaneously

BIOLOGICAL

pegfilgrastim

Given subcutaneously

BIOLOGICAL

rituximab

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

liposome-encapsulated doxorubicin citrate

Given IV

DRUG

prednisone

Given orally

DRUG

vincristine sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Pierre Soubeyran, MD, PhD · Institut Bergonié

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-02
Primary Completion
2012-12-31
Completion
2015-01-01

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911183 on ClinicalTrials.gov