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

Grenoble Alpes University Hospital Center (CHU) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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