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

University of Aarhus

Status and phase

Completed

Phase 2

Conditions

Peripheral T-Cell Lymphoma

Treatments

Drug: CHOEP + G-CSF followed by BEAM

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00791947

NLG-T-01

2006-000389-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

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.