MedTrace Logo

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2018-08-23

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

Conditions

  • Lymphoma, Large-Cell, Diffuse

Interventions

DRUG

Rituximab

375 mg/m², D1, 4 cycles

DRUG

Doxorubicin

75 mg/m², D1, 4 cycles

DRUG

Cyclophosphamide

1200 mg/m², D1, 4 cycles

DRUG

Vindesine

2 mg/m², D1, D5, 4 cycles

DRUG

Bleomycin

10 mg, D1, D5, 4 cycles

DRUG

Prednisone

60 mg, D1-D5, 4 cycles

DRUG

Prednisone

40 mg, D1-D5, 4 cycles

DRUG

Doxorubicin

50 mg/m², D1, 4 cycles

DRUG

Cyclophosphamide

750 mg/m², D1, 4 cycles

DRUG

Vincristine

1.4 mg/m², D1, 4 cycles

Sponsors & Collaborators

  • Fondation ARC

    collaborator OTHER

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Herve Tilly, MD · Lymphoma Study Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-10-16
Primary Completion
2010-04-27
Completion
2010-04-27

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00135499 on ClinicalTrials.gov