Status:
UNKNOWN
FCM Versus R-FCM Followed by R-Maintenance or Observation Only
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Lymphoma, Follicular
Lymphoma, Low-Grade
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00317096
Start Date
November 1 1998
End Date
June 1 2021
Last Update
May 7 2021
Active Locations (1)
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1
German Low Grade Study Group (Glsg)
Munich, Germany, D-81377