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Sponsors and Collaborators: |
University of Aarhus Nordic Lymphoma Group |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00791947 |
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult pateints 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.
Condition | Intervention | Phase |
---|---|---|
Peripheral T-Cell Lymphoma |
Drug: CHOEP + G-CSF followed by BEAM |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Nordic Phase II Study of Peripheral T-Cell Lymphomas Based on Dose-Intesive Induction and High-Dose Consolidation With Autologous Stem Cell Rescue |
Enrollment: | 166 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | August 2010 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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 continous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6
Ages Eligible for Study: | 18 Years to 67 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Denmark | |
Aarhus University Hospital | |
Aarhus, Denmark, 8000 | |
Copenhagen Hospital | |
Copenhagen, Denmark | |
Vejle Hospital | |
Vejle, Denmark | |
Finland | |
Kuopio University Hospital | |
Kuopio, Finland, 70211 | |
Finland, OULO | |
OULO University Hospital | |
Oulu, OULO, Finland | |
Norway | |
Oslo University Hospital | |
Oslo, Norway, 0310 | |
Rogaland Hospital | |
Rogaland, Norway | |
St.Olavs Hospital | |
Trondheim, Norway, 7006 | |
Ullevaal University Hospital | |
Oslo, Norway, 0407 |
Principal Investigator: | Francesco d'Amore, MD | Nordic Lymphoma Group |
Responsible Party: | Nordic Lymphoma Group ( Francesco d'Amore ) |
Study ID Numbers: | NLG-T-01, EudraCT no. 2006-000389-35 |
Study First Received: | November 14, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00791947 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; Finland: National Agency for Medicines |
Melphalan Prednisone Peripheral T-cell Lymphoma Immunoproliferative Disorders Carmustine Vincristine Cyclophosphamide Etoposide phosphate |
Lymphoma, T-Cell, Peripheral Lymphatic Diseases Lymphoma, T-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Etoposide Lymphoma Cytarabine |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma, T-Cell, Peripheral Lymphoma |