Trial information
A Study of MabThera (Rituximab) for Treatment of Mantle Cell Non-Hodgkin's Lymphoma After Bone Marrow or Blood Stem Cell Transplantation
Status: Completed
Protocol number: M39044
Sponsor: Roche Products Pty Limited
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the tolerability of MabThera after autologous marrow or peripheral blood stem cell transplantation in patients with mantle cell non-Hodgkin's lymphoma
Brief summary: This study will evaluate the efficacy, safety and tolerability of MabThera in patients with mantle cell lymphoma who have received high dose chemotherapy followed by autologous bone marrow or peripheral blood stem cell transplantation. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is 12.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Mantle Cell Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Progression-free survival after treatment, efficacy of B-cell depletion, immunologic recovery, median survival at follow-up, and molecular status by polymerase chain reaction assay
Key secondary outcomes: 1. Adverse events; laboratory tests, vital signs, Karnofsky index, and number of infections
Inclusion criteria:
- adult patients 18-65 years of age;
- confirmed mantle cell non-Hodgkin's lymphoma;
- newly diagnosed or relapsed disease;
- prior high-dose chemotherapy followed by autologous bone marrow or peripheral blood stem cell transplantation.
Exclusion criteria:
- previous organ transplant;
- positive test result for human immunodeficiency virus (HIV) infection;
- positive test result for hepatitis B or C virus infection;
- concurrent disease which would exclude the administration of therapy as outlined by the study protocol.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Brisbane
- Melbourne
- Parkville
- Perth
- Sydney
- Woolloongabba
