Trial information
A Study of MabThera (Rituximab) Plus Sequential High-Dose Chemotherapy in Patients Newly Diagnosed With Mantle Cell Lymphoma
Status: Completed
Protocol number: M39048
Sponsor: Roche S.p.a.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of MabThera plus high-dose sequential chemotherapy on durable clinical response in patients newly diagnosed with mantle cell lymphoma
Brief summary: This study will evaluate the efficacy and safety of MabThera plus high-dose sequential chemotherapy in patients with a new diagnosis of mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
91.
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. Rate of durable complete clinical response, defined as >=24 months of relapse-free survival
Key secondary outcomes: 1. Rate of molecular response at treatment end and study end in patients with clinical complete remission; rate of complete response, partial response, stable disease, and progressive disease at treatment end and study end. AEs and laboratory parameters
Inclusion criteria:
- adult patients 18-65 years of age;
- newly diagnosed mantle cell lymphoma;
- >=1 measurable lesion.
Exclusion criteria:
- central nervous system involvement;
- other cancer within last 5 years, except squamous cell cancer, basal cell cancer of the skin, or cancer in situ of the cervix;
- clinically significant cardiovascular disease;
- positive test result for hepatitis B or C, or for HIV.
Gender: Males or Females
Age limits: Min: 18 Years Max: 60 Years
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bergamo
- Bologna
- Milano
- Pavia
- Roma
- Torino
