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Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma

NCT00970385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2009-09-09

No results posted yet for this study

Summary

This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.

Conditions

  • Peripheral T Cell Lymphoma

Interventions

DRUG

CHOP21

CHOP regimen: * cyclophosphamide 750 mg/m2 intravenously (IV) day 1 * doxorubicin 50 mg/m2 IV day 1 * vincristine 1,4 mg/m2 (maximum 2 mg) day 1 * prednisone 100 mg/m2/D from D1 to D5.

DRUG

VIP/ABVD

VIP regimen: * etoposide 100 mg/m2/D IV from D1 to D3 * ifosfamide 1000 mg/m2/D from D1 to D5 * cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5 ABVD regimen: * doxorubicin50 mg/m2/D on D1 and D14 * bleomycin 10 mg/m2/D * vinblastine 10 mg/m2/D * dacarbazine 375 mg/m2/D

RADIATION

Radiotherapy consolidation

The treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field.

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Remy GRESSIN, MD MS · CHU Grenoble GOELAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1995-01-31
Primary Completion
2002-12-31
Completion
2008-09-30

Countries

  • France

Study Locations

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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 NCT00970385 on ClinicalTrials.gov