Status:
COMPLETED
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Nordic Lymphoma Group
Conditions:
Peripheral T-Cell Lymphoma
Eligibility:
All Genders
18-67 years
Phase:
PHASE2
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00791947
Start Date
October 1 2001
End Date
August 1 2010
Last Update
September 8 2011
Active Locations (9)
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1
Aarhus University Hospital
Aarhus, Denmark, 8000
2
Copenhagen Hospital
Copenhagen, Denmark
3
Vejle Hospital
Vejle, Denmark
4
OULO University Hospital
Oulu, Oulo, Finland