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A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue

Phase 2
18 Years
67 Years
Not Enrolling
Peripheral T-Cell Lymphoma

Thank you

Trial Information

A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Time to treatment failure

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Francesco d'Amore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nordic Lymphoma Group


Denmark: Danish Medicines Agency

Study ID:




Start Date:

October 2001

Completion Date:

August 2010

Related Keywords:

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