Trial information
A Study of MabThera (Rituximab) in Patients With HIV-Related Non-Hodgkin's Lymphoma
Status: Completed
Protocol number: M39029
Sponsor: Roche Austria GmbH
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the capacity of MabThera plus first-line treatment with infusional CDE to induce a clinical response in patients with HIV-related non-Hodgkin's lymphoma
Brief summary: This study will evaluate the efficacy and safety of MabThera plus chemotherapy in patients with HIV-related non-Hodgkin`s lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
13.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Clinical response, overall and progression-free survival, effect on minimal residual disease measured by polymerase chain reaction
Key secondary outcomes: 1. Clinical adverse events and laboratory parameters
Inclusion criteria:
- adult patients 19-65 years of age;
- non-Hodgkin's lymphoma;
- positive test result for human immunodeficiency virus (HIV).
Exclusion criteria:
- primary CNS lymphoma;
- active infections (except HIV, hepatitis B or C);
- prior anti-CD20 treatment (including IDEC-C2B8);
- history of malignancy other than squamous cell cancer, basal cell cancer of the skin, or in situ cancer of the cervix within the last 5 years, localized Kaposi sarcoma;
- prior history of allergic reactions against monoclonal antibodies.
Gender: Males or Females
Age limits: Min: 19 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
