Open, Multicentral, Randomised Phase II Study of Allogene Stem Cell Transplantation After Pretreatment With Fludarabin, Busulfan, Cyclophospahmid and GVHD-Prophylaxis With or Without Rituximab in Patients With Recidivation of High Grade Non-Hodgkin's Lymphoma in Special Risk Situation in the Age of 18 - 65
Patients in the age of 18 to 65 years with a high- risk relapse of a histology proven
aggressive Non-Hodgkin's-lymphoma are eligible for the trial. Aggressive Non-Hodgkin's
lymphoma within this study is defined as:
follicular lymphoma grade III° lymphoblastic (precursor) lymphoma diffuse large cell cell
lymphoma any subtype and variant including primary mediastinal lymphoma mantle cell
lymphoma, blastic variant
precursor T cell lymphoma peripheral T cell lymphoma, any subtype and variant
angioimmunoblastic lymphoma anaplastic large cell lymphoma, any subtype NK / T cell lymphoma
High risk relapsed or progressive disease is defined as (a) primary progressive disease, (b)
early relapse after less than 12 month of remission duration and at least one risk factor
according to the international prognostic index (IPI), (c) relapse or progression after high
dose chemotherapy and autologous transplantation, (d) relapse or progression and lack of an
autologous stem cell product.
Patients with this type of progression / relapse should receive rituximab plus
ifosfamide/carboplatin/etoposide (R-ICE) or rituximab plus dexamethasone/high dose
ARA-C/cisplatinum as salvage therapy (recommendation, not part of study medication). In
patients biwth T cell lymphoma rituximab may be replaced by alemtuzumab. If at least stable
disease is achieved, patients can be definitely included.
With inclusion, patients were randomized to receive either 375 mg/ m2 of rituximab at weeks
3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation or no additional
Conditioning for transplantation consisted of Fludarabine 125 mg/m2, Busulfan 12 mg/kg and
cyclophosphamide 120 mg/kg.
Short-term (day 1 to day 28) mycophenolat mofetil and tacrolimus are used as basis GVHD
prophylaxis in all patients. Anti-thymocyte globulin can be used due to the centres decision
in patients with unrelated donors
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment. (a) rate of acute GVHD grade II-IV after one year
One year after allogeneic stem cell transplantation
Bertram Glass, Prof. MD.
Asklepios Klinik St. Georg
Germany: Federal Institute for Drugs and Medical Devices