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A Nordic Phase II Study of Peripheral T-Cell Lymphomas Based on Dose-Intesive Induction and High-Dose Consolidation With Autologous Stem Cell Rescue
This study is ongoing, but not recruiting participants.
First Received: November 14, 2008   No Changes Posted
Sponsors and Collaborators: University of Aarhus
Nordic Lymphoma Group
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00791947
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Time to treatment failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

    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

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, psy-chiatric, 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 com-pliance and follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791947

Locations
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
Sponsors and Collaborators
University of Aarhus
Nordic Lymphoma Group
Investigators
Principal Investigator: Francesco d'Amore, MD Nordic Lymphoma Group
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009