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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000389-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Nordic Lymphoma Group | NETWORK |
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This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.
The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOEP + G-CSF followed by BEAM | Drug | CHOEP: Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5 BEAM: Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
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Inclusion Criteria:
Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco d'Amore, MD | Nordic Lymphoma Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| Copenhagen Hospital |
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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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| Copenhagen |
| Denmark |
| Vejle Hospital | Vejle | Denmark |
| OULO University Hospital | Oulu | Oulo | Finland |
| Kuopio University Hospital | Kuopio | 70211 | Finland |
| Oslo University Hospital | Oslo | 0310 | Norway |
| Ullevaal University Hospital | Oslo | 0407 | Norway |
| Rogaland Hospital | Rogaland | Norway |
| St.Olavs Hospital | Trondheim | 7006 | Norway |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |