NCT00791947CompletedPhase 2
A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 166
- Locations
- 14
- Primary Endpoint
- Time to treatment failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time to treatment failure
Time Frame: 5 years
Secondary Outcomes
- Overall survival(5 years)
Investigators
Study Sites (14)
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