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NCT Number: NCT00970385

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

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.

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Key information

Conditions

Peripheral T Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr REMY GRESSIN

Grenoble, 38043, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHOP21

Drug

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.

Other names: CHOP 21 arm

VIP/ABVD

Drug

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

Other names: VIP/ABVD Arm

Radiotherapy consolidation

Radiation

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.

Other names: Consolidation treatment

Primary outcomes

  1. Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.

    Time frame: 2 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 6 years

  2. response rate at the end of the treatment

    Time frame: 6-8 months

  3. progression free survival (PFS)

    Time frame: 6 years

  4. hematotoxicity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • French Innovative Leukemia Organisation

Registry information

Official study title

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

Acronym: LTP

Important dates

Study start
1995
Primary completion
2002
Study completion
2008
First posted
Sep 2, 2009
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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