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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791947
• Other study ID #: NLG-T-01
• Secondary ID: 2006-000389-35
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2008
• Last updated: September 7, 2011
• Start date: October 2001
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyNorway: Norwegian Medicines AgencySweden: Medical Products AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Intervention

Drug:
• CHOEP + 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Nordic Lymphoma Group

Countries where clinical trial is conducted

Denmark,  Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure		5 years	No
Secondary	Overall survival		5 years	No