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NCT Number: NCT00791947

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

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.

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHOEP + G-CSF followed by BEAM

Drug

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 outcomes

  1. Time to treatment failure

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Nordic Lymphoma Group

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2008
Study completion
2010
First posted
Nov 17, 2008
Registry last updated
Sep 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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