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

This study has been completed.
Sponsor:
Collaborator:
GOELAMS = Groupe Est Ouest Leucémies et Autres Maladies du Sang
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00970385
First received: August 20, 2009
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Peripheral T Cell Lymphoma
Drug: CHOP21
Drug: VIP/ABVD
Radiation: Radiotherapy consolidation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • response rate at the end of the treatment [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • progression free survival (PFS) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • hematotoxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: January 1995
Study Completion Date: September 2008
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHOP 21

Induction therapy CHOP every 21 days:

  • 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: 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.
Other Name: CHOP 21 arm
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.
Other Name: Consolidation treatment
Experimental: VIP/ABVD arm

VIP cycle:

  • etoposide 100 mg/m2/D IV from D1 to D3
  • ifosfamide 1000 mg/m2/D from D1 to D5
  • cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5

ABVD cycle:

  • doxorubicin50 mg/m2/D on D1 and D14
  • bleomycin 10 mg/m2/D
  • vinblastine 10 mg/m2/D
  • dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD).
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
Other Name: VIP/ABVD Arm
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.
Other Name: Consolidation treatment

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970385

Locations
France
Dr REMY GRESSIN
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
GOELAMS = Groupe Est Ouest Leucémies et Autres Maladies du Sang
Investigators
Principal Investigator: Remy GRESSIN, MD MS CHU Grenoble GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: CHU Grenoble/ Dr Rémy GRESSIN, GOELAMS
ClinicalTrials.gov Identifier: NCT00970385     History of Changes
Other Study ID Numbers: LTP 95
Study First Received: August 20, 2009
Last Updated: September 8, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 23, 2014