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

A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue

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.

Study Overview

• Status: Completed
• Conditions: Peripheral T-Cell Lymphoma
• Intervention / Treatment: Drug: CHOEP + G-CSF followed by BEAM

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Copenhagen, Denmark
    • Copenhagen Hospital
  • Vejle, Denmark
    • Vejle Hospital
• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital
  • Oulo
    • Oulu, Oulo, Finland
      • OULO University Hospital
• Norway
  • Oslo, Norway, 0407
    • Ullevaal University Hospital
  • Oslo, Norway, 0310
    • Oslo University Hospital
  • Rogaland, Norway
    • Rogaland Hospital
  • Trondheim, Norway, 7006
    • St.Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to treatment failure	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Nordic Lymphoma Group
• Investigators: Principal Investigator: Francesco d'Amore, MD, Nordic Lymphoma Group

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: November 14, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): September 8, 2011
• Last Update Submitted That Met QC Criteria: September 7, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: NLG-T-01; 2006-000389-35 (EudraCT Number)