FCM Versus R-FCM Followed by R-Maintenance or Observation Only
This trial is active, not recruiting.
|Conditions||lymphoma, follicular, lymphoma, low-grade, lymphoma, intermediate-grade|
|Treatments||fcm, r-fcm, rituximab maintenance, observation only|
|Sponsor||Ludwig-Maximilians - University of Munich|
|Start date||November 1998|
|End date||June 2001|
|Trial size||319 participants|
|Trial identifier||NCT00317096, NHL-1998-1|
The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy (R-FCM) 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 FL, MCL and LP lymphoma.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
Event free interval
Time to Progression
serious infectious complications
Male or female participants at least 18 years old.
Inclusion Criteria - patients with histologically proven stage III/IV centroblastic/centrocytic (FL), centrocytic (MCL)or lymphoplasmacytoid lymphoma (LPIC). - relapsed disease after initial chemotherapy or peripheral blood stem cell transplantation - two-dimensionally measurable lesion outside a previously irradiated area (osteoblastic bone lesions, ascites, and pleural effusions are not evaluable) - age > 18 years - Karnofsky-index > 60 - life expectancy of at least 3 months - effective contraception in female premenopausal patients - patient's written informed consent Exclusion Criteria: - age < 18 years - Karnofsky-index < 60 - treatment with fludarabine or mitoxantrone within the preceding three months - active auto-immune hemolytic anemia at the start of FCM chemotherapy - participation in another clinical trial during the last 4 weeks - participation in this study before - previous treatment with murine antibodies - concurrent diseases which exclude the administration of therapy as outlined by the study protocol - non-compensated heart failure - dilatative cardiomyopathy - coronary heart disease with ST segment depression in ECG - myocardial infarction during the last 6 months - chronic lung disease with hypoxemia - severe non-compensated hypertension - severe non-compensated diabetes mellitus - renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma - hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels > 2.0 mg/dl, not related to lymphoma - clinical signs of cerebral dysfunction - women during lactation or pregnancy or of childbearing potential not using a reliable contraceptive method - severe psychiatric disease - serological positivity for HBV, HCV, HIV - previous organ transplantation other than autologous peripheral blood stem cell transplantation - missing written informed consent or missing written consent for data protection
|Official title||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|
|Principal investigator||Hiddemann Wolfgang, PhD|
|Description||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.|
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