Status:
COMPLETED
Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
French Innovative Leukemia Organisation
Conditions:
Peripheral T Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- cutaneous form of PTCL
- previous treatment
- age \< 18 and \> 70
- performance status \> 2
- abnormal cardiac or hepatic functions
- HIV-, HCV- or HBV- positivity
Key Trial Info
Start Date :
January 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00970385
Start Date
January 1 1995
End Date
September 1 2008
Last Update
September 9 2009
Active Locations (1)
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1
Dr REMY GRESSIN
Grenoble, France, 38043