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