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

Primary Purpose

Peripheral T Cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
CHOP21
VIP/ABVD
Radiotherapy consolidation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dr REMY GRESSIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHOP 21

VIP/ABVD arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
response rate at the end of the treatment
progression free survival (PFS)
hematotoxicity

Full Information

First Posted
August 20, 2009
Last Updated
September 8, 2009
Sponsor
University Hospital, Grenoble
Collaborators
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00970385
Brief Title
Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
Acronym
LTP
Official Title
Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble
Collaborators
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHOP 21
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VIP/ABVD arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
CHOP21
Other Intervention Name(s)
CHOP 21 arm
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
VIP/ABVD
Other Intervention Name(s)
VIP/ABVD Arm
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy consolidation
Other Intervention Name(s)
Consolidation treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
6 years
Title
response rate at the end of the treatment
Time Frame
6-8 months
Title
progression free survival (PFS)
Time Frame
6 years
Title
hematotoxicity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remy GRESSIN, MD MS
Organizational Affiliation
CHU Grenoble GOELAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr REMY GRESSIN
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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