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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Peripheral T Cell Lymphoma

Intervention / Treatment
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* Drug: CHOP21
* Drug: VIP/ABVD
* Radiation: Radiotherapy consolidation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHOP 21<br>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<br>* 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.<br>* Other names: CHOP 21 arm;Radiation: Radiotherapy consolidation<br>* 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.<br>* Other names: Consolidation treatment;|
| Experimental: VIP/ABVD arm<br>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<br>* 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<br>* Other names: VIP/ABVD Arm;Radiation: Radiotherapy consolidation<br>* 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.<br>* Other names: Consolidation treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 6 years | 
| response rate at the end of the treatment |  | 6-8 months | 
| progression free survival (PFS) |  | 6 years | 
| hematotoxicity |  | 6 months |