Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2007

Trial Registration Date: 08/15/2007

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:54:10 PM