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

Primary Purpose

Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CHOEP + G-CSF followed by BEAM
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aarhus University Hospital
  • Copenhagen Hospital
  • Vejle Hospital
  • OULO University Hospital
  • Kuopio University Hospital
  • Oslo University Hospital
  • Ullevaal University Hospital
  • Rogaland Hospital
  • St.Olavs Hospital

Outcomes

Primary Outcome Measures

Time to treatment failure

Secondary Outcome Measures

Overall survival

Full Information

First Posted
November 14, 2008
Last Updated
September 7, 2011
Sponsor
University of Aarhus
Collaborators
Nordic Lymphoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT00791947
Brief Title
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

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Nordic Lymphoma Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CHOEP + G-CSF followed by BEAM
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to treatment failure
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco d'Amore, MD
Organizational Affiliation
Nordic Lymphoma Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Copenhagen Hospital
City
Copenhagen
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
OULO University Hospital
City
Oulu
State/Province
Oulo
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Rogaland Hospital
City
Rogaland
Country
Norway
Facility Name
St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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