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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970385

Acronym

LTP

Enrollment

Registered

2009-09-02

Start date

1995-01-31

Completion date

2008-09-30

Last updated

2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T Cell Lymphoma

Brief 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

Interventions

DRUGVIP/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

DRUGCHOP21

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.

RADIATIONRadiotherapy 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.	2 years

Secondary

Measure	Time frame
Overall survival (OS)	6 years
response rate at the end of the treatment	6-8 months
progression free survival (PFS)	6 years
hematotoxicity	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026