Clinical trial NCT00791947: A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-Cell Lymphoma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Nordic Lymphoma Group
First posted: 2008-11-17
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to treatment failure
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Oulu
country: Finland
facility: OULO University Hospital
state: Oulo
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Rogaland
country: Norway
facility: Rogaland Hospital
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: Nordic Lymphoma Group
name: Francesco d'Amore, MD
role: PRINCIPAL_INVESTIGATOR
References: