Trial information
A Dose-Escalating Study of R7159 in Patients With CD20+ Malignant Disease.
Status: Recruiting
Protocol number: BO20999
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, dose-escalating study to investigate the safety and tolerability of R7159 monotherapy in patients with CD20+ malignant disease
Brief summary: This study will investigate the safety and tolerability of intravenous R7159 monotherapy, in patients with CD20+ malignant disease. Having identified the recommended dose for further investigation, the efficacy and safety of this dose will be investigated in 4 different patient populations: diffuse large beta-cell lymphoma (DLBCL), follicular non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 97.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Lymphomas
Intervention type: Drug
Intervention name: R7159
Primary outcome: 1. Phase 1: Incidence of dose-limiting toxicity. Time frame: Event driven
2. Phase 2: Overall best response rate Time frame: Event driven
Key secondary outcomes: 1. Complete and partial response rates, progression-free survival. Time frame: Event driven
2. AEs, laboratory parameters, pharmacokinetic and pharmacodynamic parameters. Time frame: Event driven
Inclusion criteria:
- adult patients, >=18 years of age;
- part 1 only: CD20+ malignant disease (lymphoma or CLL);
- part 2 only: relapsed or refractory DLBCL, follicular NHL, CLL or MCL.
Exclusion criteria:
- prior use of any investigational antibody therapy or other agent within 6 months of study start;
- prior use of any anti-cancer vaccine;
- prior use of MabThera within 8 weeks of study entry;
- CNS lymphoma.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2007
Trial registration date: 08/15/2007
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Bobigny
- Creteil
- Le Mans
- Lille
- Montpellier
- Nantes
- Paris
- Pessac
- Pierre Benite
- Rennes
- Rouen
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
Germany
- Essen
- Heidelberg
- Kiel
- Köln
- Mainz
- München
- Münster
- Ulm
- Würzburg
