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Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma

NCT00136565 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-23

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP \[doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone\]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Velcade

1.5 mg/m², D1, D5, 4 cycles

DRUG

Doxorubicin

75 mg/m², D1, 4 cycles

DRUG

Prednisone

60 mg/m², D1-D5, 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

Sponsors & Collaborators

  • Janssen-Cilag International NV

    collaborator INDUSTRY

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Bertrand Coiffier, MD · Hospices Civils de Lyon, Lyon, France

  • Alain Delmer, MD · Centre Hospitalier Robert Debré

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-01-08
Primary Completion
2011-04-18
Completion
2011-04-18

Countries

  • Belgium
  • France

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 NCT00136565 on ClinicalTrials.gov