FCM Versus R-FCM Followed by R-Maintenance or Observation Only

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Rituximab

Criteria

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