Peripheral T-Cell Lymphoma Clinical Trial
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
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.
Status | Completed |
Enrollment | 166 |
Est. completion date | August 2010 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 67 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Copenhagen Hospital | Copenhagen | |
Denmark | Vejle Hospital | Vejle | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | OULO University Hospital | Oulu | Oulo |
Norway | Oslo University Hospital | Oslo | |
Norway | Ullevaal University Hospital | Oslo | |
Norway | Rogaland Hospital | Rogaland | |
Norway | St.Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Nordic Lymphoma Group |
Denmark, Finland, Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to treatment failure | 5 years | No | |
Secondary | Overall survival | 5 years | No |
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