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

September 7, 2011 updated by: University of Aarhus

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Nordic Lymphoma Group

Investigators

Principal Investigator: Francesco d'Amore, MD, Nordic Lymphoma Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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