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| Name | Class |
|---|---|
| French Innovative Leukemia Organisation | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHOP 21 | Active Comparator | Induction therapy CHOP every 21 days:
|
|
| VIP/ABVD arm | Experimental | VIP cycle:
ABVD cycle:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOP21 | Drug | CHOP regimen:
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 6 years | |
| response rate at the end of the treatment | 6-8 months | |
| progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Remy GRESSIN, MD MS | CHU Grenoble GOELAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr REMY GRESSIN | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C034587 | CHOP protocol |
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|
| VIP/ABVD | Drug | VIP regimen:
ABVD regimen:
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|
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| Radiotherapy consolidation | Radiation | 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. |
|
|
| 6 years |
| hematotoxicity | 6 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |