Treatment of Relapsed CBCC, CC and LPIC Lymphoma With FCM Chemotherapy Alone or in Combination With the Monoclonal Anti CD 20 Antibody Rituximab Followed by Anti-CD 20 Maintenance or Observation Only
Patients with relapsed centroblastic/centrocytic (FL), centrocytic (MCL)or
lymphoplasmacytoid lymphoma are randomly assigned to either FCM chemotherapy alone or to FCM
chemotherapy in combination with the monoclonal anti-CD20 antibody rituximab (R-FCM). FCM
chemotherapy will be given for 4 cycles in intervals of 4 weeks.
In patients assigned to cytoreductive therapy with FCM plus rituximab, the monoclonal
antibody is given as one infusion (375 mg/m2) on the day before the respective FCM course
for a total of four applications.
Four weeks after the end of FCM chemotherapy patients with CR or PR are randomly assigned to
either no further treatment or maintenance therapy with rituximab. Rituximab will be given 4
times (one infusion per week with 375 mg/m2). After six months rituximab treatment will be
repeated with another 4 infusions.
In case of relapse patients will receive an alternative treatment according to the decision
of the investigator.
The aim of this phase III trial is to assess the safety and efficacy of treatment with
rituximab in combination with FCM chemotherapy versus FCM chemotherapy alone for remission
induction and to asses the safety and efficacy of rituximab maintenance versus observation
only after response to induction therapy. Both questions are addressed in way of a
prospective randomized comparison in patients with relapsed FCL, MCL and LP lymphoma.
Primary objectives of this trial are to compare (1) the remission rates (CR and PR) achieved
after FCM plus rituximab versus FCM alone and (2) the progression free interval of rituximab
maintenance versus observation only.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hiddemann Wolfgang, PhD
University Hospital Großhadern/LMU, Dept. of Medicine III
Germany: Ethics Commission