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A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791947
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : September 8, 2011
Nordic Lymphoma Group
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Peripheral T-Cell Lymphoma Drug: CHOEP + G-CSF followed by BEAM Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
Study Start Date : October 2001
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Intervention Details:
  • Drug: CHOEP + G-CSF followed by BEAM


    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


    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

Primary Outcome Measures :
  1. Time to treatment failure [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (<10cm) can be treated individually at the discretion of the responsible physician.
  • Following histologic subtypes (WHO classification) are eligible for inclusion in the study:

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

  • Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
  • formed consent based on oral and written patient information (Appendix I)

Exclusion Criteria:

  • Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
  • Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
  • WHO Performance Status grade 4 (Appendix II)
  • Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
  • Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
  • Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Patients with seropositivity for the human immunodeficiency virus.
  • Patients with other active and therapeutically uncontrolled infection.
  • Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00791947

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Aarhus University Hospital
Aarhus, Denmark, 8000
Copenhagen Hospital
Copenhagen, Denmark
Vejle Hospital
Vejle, Denmark
OULO University Hospital
Oulu, Oulo, Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Oslo University Hospital
Oslo, Norway, 0310
Ullevaal University Hospital
Oslo, Norway, 0407
Rogaland Hospital
Rogaland, Norway
St.Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
University of Aarhus
Nordic Lymphoma Group
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Principal Investigator: Francesco d'Amore, MD Nordic Lymphoma Group
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Responsible Party: University of Aarhus Identifier: NCT00791947    
Other Study ID Numbers: NLG-T-01
2006-000389-35 ( EudraCT Number )
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin