Lymphoma, Follicular Clinical Trial
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
Verified date | May 2021 |
Source | Ludwig-Maximilians - University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 319 |
Est. completion date | June 2021 |
Est. primary completion date | June 2001 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | German Low Grade Study Group (Glsg) | Munich |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Germany,
Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, c — View Citation
Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a signific — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission rate | |||
Primary | Event free interval | |||
Secondary | Time to Progression | |||
Secondary | Overall survival | |||
Secondary | adverse events | |||
Secondary | serious infectious complications |
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