Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
NCT ID: NCT00970385
Last Updated: 2009-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
1995-01-31
2008-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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).
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
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.
Interventions
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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.
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* previous treatment
* age \< 18 and \> 70
* performance status \> 2
* abnormal cardiac or hepatic functions
* HIV-, HCV- or HBV- positivity
18 Years
70 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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GOELAMS
Principal Investigators
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Remy GRESSIN, MD MS
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble GOELAMS
Locations
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Dr REMY GRESSIN
Grenoble, , France
Countries
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Other Identifiers
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LTP 95
Identifier Type: -
Identifier Source: org_study_id
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