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

Peripheral T Cell Lymphoma Clinical Trial

— LTP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970385
• Other study ID #: LTP 95
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2009
• Last updated: September 8, 2009
• Start date: January 1995
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2008
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• newly diagnosed untreated PTCL

• age 18 and 70 years

• performance status = 2

• Ann Arbor stage I to IV

• normal cardiac ventricular ejection fraction over 50%

• normal hepatic function (asat, ALAT, PAL < 2.5 ULN)

Exclusion Criteria:

• cutaneous form of PTCL

• previous treatment

• age < 18 and > 70

• performance status > 2

• abnormal cardiac or hepatic functions

• HIV-, HCV- or HBV- positivity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Dr REMY GRESSIN	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	French Innovative Leukemia Organisation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.		2 years	Yes
Secondary	Overall survival (OS)		6 years	Yes
Secondary	response rate at the end of the treatment		6-8 months	Yes
Secondary	progression free survival (PFS)		6 years	Yes
Secondary	hematotoxicity		6 months	Yes