Last updated: May 6, 2021
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Not Recruiting
Phase
3
Condition
Lymphoma
Follicular Lymphoma
Treatment
N/AClinical Study ID
NCT00317096
NHL-1998-1
Ages > 18 All Genders
Study Summary
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 celltransplantation
- two-dimensionally measurable lesion outside a previously irradiated area (osteoblasticbone 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
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 thestudy 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 valuesand/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 reliablecontraceptive method
- severe psychiatric disease
- serological positivity for HBV, HCV, HIV
- previous organ transplantation other than autologous peripheral blood stem celltransplantation
- missing written informed consent or missing written consent for data protection
Study Design
Total Participants: 319
Study Start date:
November 01, 1998
Estimated Completion Date:
June 30, 2021
Study Description
Connect with a study center
German Low Grade Study Group (Glsg)
Munich, D-81377
GermanySite Not Available
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