Peripheral (mature) T-cell lymphoma, first diagnosis, ALK-negative
Conditions
Interventions
Product Name: autologous stem cells
Product Code: ASC
Pharmaceutical Form: Living tissue equivalent
Product Name: allogeneic stem cells
Product Code: allo SC
Pharmaceutical Form: Living tissue equiva
Sponsors
University Medicine Goettingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary diagnosis of mature T-cell lymphoma, age 18-60 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Stage one with aaIPI0, ALK positive anaplastic large cell lymphoma, T-lymphoblastic lymphoma, HIV positivity, major organ dysfunction, pregnancy, patient unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does primary allogeneic transplantation lead to a 25% improvement of EFS at 3 years compared to autologous transplantation?;Secondary Objective: further endpoints are efficacy, short term and long term side effects, adherence to protocol and withdrawal from therapy, endpoints concerning transplantation. ;Primary end point(s): Event free survival defined by the time between day of randomization until one of the following events occurs, whichever comes first: disease progression during therapy, institution of any additional unplanned anti-tumour-treatment, relapse after achievement of CR/Cru, death due to any cause | — |
Countries
Germany
Outcome results
None listed