Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- adult patients >=18 years of age;
- confirmed chronic phase myelogenous leukemia diagnosed within 12 months before start of study.
Exclusion criteria:
- previous interferon therapy or treatment with any investigational agents;
- fertile men or women unless surgically sterile or using adequate contraceptive methods, and pregnant or lactating women;
- candidates for bone marrow transplant within the next 6 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Bulgaria
Canada
- Halifax, NS
- London, ON
- Ottawa, ON
- Toronto, ON
China
Czech Republic
France
- Lille
- Lyon
- Paris
- Pessac
- Poitiers
- Strasbourg
Germany
- Hannover
- Mainz
- Mannheim
- Tübingen
Hungary
India
- Ahmedabad
- Hyderabad
- Lucknow
- Trivandrum
Israel
Italy
- Bari
- Bologna
- Pavia
- Pisa
- Roma
- Torrette di Ancona
- Udine
Mexico
Poland
Russian Federation
Slovakia
- Banska Bystrica
- Bratislava
- Kosice
South Africa
- Cape Town
- Durban
- Johannesburg
Spain
Taiwan
Thailand
United Kingdom
United States
- Phoenix, AZ
- Los Angeles, CA
- Santa Rosa, CA
- Wilmington, DE
- New Orleans, LA
- New York, NY
- Stony Brook, NY
- Memphis , TN
