Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- adult patients 18-75 years of age;
- chronic myelogenous leukemia;
- previous participation in PEGASYS study ML16544, NO16006 or ML17228.
Exclusion criteria:
None stated
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: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Freiburg
- Mainz
- Mannheim
- Marburg
- Tübingen
