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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014