Trial information
A Study of Mircera in Patients With Non-Hodgkin's Lymphoma and Anemia.
Status: Completed
Protocol number: BA16728
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of subcutaneous Mircera on hemoglobin level/correction in patients with anemia and aggressive or indolent B-cell non-Hodgkin's lymphoma
Brief summary: This study will evaluate the efficacy and safety of different subcutaneous doses of Mircera to treat anemia in patients with non-Hodgkin's lymphoma (NHL) who are receiving combination chemotherapy. The anticipated time on study treatment is < 3 months and the target sample size is <100 individuals.
Target sample size is 93.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta[Mircera]
Primary outcome: 1. Efficacy: Time-adjusted average hemoglobin value between baseline and end of initial treatment
Key secondary outcomes: 1. Efficacy: Change in Hb, Hct, and reticulocyte count; Hb and hematopoietic response
Safety: Vital signs, AEs, laboratory values
Inclusion criteria:
- adult patients >=18 years of age;
- NHL;
- anemia;
- receiving combination chemotherapy.
Exclusion criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within the 30 days preceding the first dose of study medication, or during the study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Canada
- St John'S
- Halifax, NS
- Ottawa, ON
- Toronto, ON
Czech Republic
Germany
Italy
- Bergamo
- Firenze
- Modena
- Pavia
- Roma
Poland
- Gdansk
- Lodz
- Lublin
- Warszawa
Spain
- Barcelona
- Hospitalet de Llobregat
- Madrid
- Toledo
- Zaragoza
Sweden
- Goeteborg
- Malmoe
- Stockholm
- Sundsvall
