Trial Information

Summary: Expanded Access Program - A Study Providing Long-Term Treatment with PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Myelogenous Leukemia

Status: No longer recruiting

Protocol Number: ML17395

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: An open-label expanded access study of the efficacy, safety, and tolerability of long-term use of PEGASYS in patients with chronic myelogenous leukemia who have previously participated in PEGASYS study ML16544, NO16006, or ML17228

Brief Summary: This study will evaluate the efficacy and safety of long-term use of PEGASYS in patients with chronic myelogenous leukemia who have previously participated in PEGASYS study ML16544, NO16006 or ML17228. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is 20.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Condition: Myelogenous Leukemia, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Efficacy: general efficacy measures throughout study

Key Secondary Outcomes: 1. Safety: Laboratory parameters and adverse events Tolerability: Premature withdrawals due to adverse events or laboratory abnormalities

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2003

Trial Registration Date: 11/01/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 3:18:48 PM