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

Phase 2

Completed

• Conditions: Peripheral T-Cell Lymphoma

• Registration Number: NCT00791947
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2008-08
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Study Completion: 2010-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-07
• Last Update Posted: 2011-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to treatment failure	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (9)

Ullevaal University Hospital; 🇳🇴 Oslo, Norway

OULO University Hospital; 🇫🇮 Oulu, Oulo, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oslo University Hospital; 🇳🇴 Oslo, Norway

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark

Copenhagen Hospital; 🇩🇰 Copenhagen, Denmark

Rogaland Hospital; 🇳🇴 Rogaland, Norway

St.Olavs Hospital; 🇳🇴 Trondheim, Norway