Allo-hNHL (FluBuCy)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the
      efficacy of rituximab as a prophylactic medication for prevention of
      graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients
      with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important
      secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in
      this clinical situation.
    

Detailed description: 
      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:

      B-NHL:

      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

      T-NHL:

      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
      medication.

      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
    

Intervention name(s): standard GVHD prophylaxis; rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Application of tacrolimus from day -1 with a goal of tacrolimus serum concentration of 10 ng / ml Aplication of mycophenolat mofetil from day +1 to day +28 in a dose of 2 x 1g per day; Patients receiving 375 mg/ m2 of rituximab at weeks 3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation in addition to standard GVHD prophylaxis (tacrolimus with aimed serum level of 10 ng / ml and mycophenolat mofetil 2 x 1 g p.o. day 1 to 28 after allogeneic SZT
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rituximab; Non-Hodgkin's lymphoma; diffuse large B cell lymphoma; peripheral t cell lymphoma; graft-versus-host disease; graft-versus-lymphoma effect; allogeneic haematopoietic stem cell transplantation; relapsed or primary progressive aggressive Non-Hodgkin's lymphoma