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

This study has been completed.
Sponsor:
Collaborator:
Nordic Lymphoma Group
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00791947
First received: November 14, 2008
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Peripheral T-Cell Lymphoma
Drug: CHOEP + G-CSF followed by BEAM
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
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 continuous 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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
OULO University Hospital
Oulu, Oulo, Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Oslo University Hospital
Oslo, Norway, 0310
Rogaland Hospital
Rogaland, Norway
St.Olavs Hospital
Trondheim, Norway, 7006
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: University of Aarhus
ClinicalTrials.gov Identifier: NCT00791947     History of Changes
Other Study ID Numbers: NLG-T-01, 2006-000389-35
Study First Received: November 14, 2008
Last Updated: September 7, 2011
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 19, 2014