Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) versus Roferon-A (Interferon alfa-2a, Recombinant) in Patients With Recently Diagnosed Chronic Myelogenous Leukemia

Status: Completed

Protocol Number: NO16006

Sponsor: Hoffmann-La Roche Inc

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of PEGASYS versus Roferon-A on cytogenetic response in patients with chronic myelogenous leukemia

Brief Summary: This study will evaluate the safety and efficacy of PEGASYS compared with Roferon-A in patients with recently diagnosed chronic phase myelogenous leukemia who have not received prior interferon therapy. The anticipated time on study treatment is 12 months or until progressive disease and the target sample size is 500+ individuals. Target sample size is 145.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Myelogenous Leukemia, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD)[PEGASYS]

Primary Outcome: 1. Efficacy: Major cytogenetic response based on karyotypic analysis, and complete hematologic response, at 12 months

Key Secondary Outcomes: 1. Safety: Adverse events, laboratory tests results, vital signs, survival rate at 2 years

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 3:18:54 PM