Clinical trial · Interventional
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOEP + G-CSF followed by BEAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to treatment failure
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 67 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available