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R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma

NCT00144755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2015-09-02

No results posted yet for this study

Summary

This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large B-cell lymphoma.

Conditions

  • Diffuse Large Cell Lymphoma

Interventions

DRUG

Darbepoetin alfa

prophylactic administration of darbepoetin alfa in experimental arm

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Richard Delarue, MD · Lymphoma Study Association

  • André Bosly, MD · Lymphoma Study Association

  • Corinne Haioun, MD · Lymphoma Study Association

  • Hervé Tilly, MD · Lymphoma Study Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

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 NCT00144755 on ClinicalTrials.gov