Peripheral T-Cell Lymphoma
Conditions
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.
Interventions
DRUGCHOEP + G-CSF followed by BEAM
CHOEP: Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5 BEAM: Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6
Sponsors
Nordic Lymphoma Group
University of Aarhus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 years |
Countries
Denmark, Finland, Norway
Outcome results
None listed