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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Peripheral T Cell Lymphoma

Treatments: Drug: CHOP21; Drug: VIP/ABVD; Radiation: Radiotherapy consolidation

Study type: Interventional

Funder types: Other

Identifiers

NCT00970385

LTP 95

Details and patient eligibility

About

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.

Full 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

Enrollment: 95 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

CHOP 21

Active Comparator group

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.

Treatment:

Radiation: Radiotherapy consolidation

Drug: CHOP21

VIP/ABVD arm

Experimental group

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).

Treatment:

Radiation: Radiotherapy consolidation

Drug: VIP/ABVD