NCT00970385

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

Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Induction therapy: ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days Consolidation therapy: For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1995-01-01
• Primary completion: 2002-12-01
• Completion: 2008-09-01
• First posted: 2009-09-02
• Last updated: 2009-09-09

Locations

1 site across 1 country: France