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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT00970385
Collaborator
French Innovative Leukemia Organisation (Other)
95
Enrollment
1
Location
2
Arms
164
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jan 1, 1995
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Consolidation treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL. [2 years]

    Secondary Outcome Measures

    1. Overall survival (OS) [6 years]

    2. response rate at the end of the treatment [6-8 months]

    3. progression free survival (PFS) [6 years]

    4. hematotoxicity [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Dr REMY GRESSIN Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble
    • French Innovative Leukemia Organisation

    Investigators

    • Principal Investigator: Remy GRESSIN, MD MS, CHU Grenoble GOELAMS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00970385
    Other Study ID Numbers:
    • LTP 95
    First Posted:
    Sep 2, 2009
    Last Update Posted:
    Sep 9, 2009
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral

    Study Results

    No Results Posted as of Sep 9, 2009