Trial information
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
Status: No longer recruiting
Protocol number: ML20559
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effects of a combination of NeoRecormon, CellCept and prednisone on hematological parameters and cytogenesis in patients with low or intermediate risk myelodysplastic syndromes.
Brief summary: This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Myelodysplastic Syndromes
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Incidence of complete remission (transfusions, hematology parameters, bone marrow aspirates) Time frame: Week 12
2. Cytogenesis assessments of bone marrow Time frame: Weeks 24 and 52
Key secondary outcomes: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- diagnosis of MDS, according to IPSS criteria;
- low or intermediate risk, who are not candidates for treatment with growth factors, or who have not responded to these treatments.
Exclusion criteria:
- previous treatment with CellCept, or any erythropoietin-stimulating drug;
- diagnosis of proliferative chronic myelomonocytic leukemia;
- prior or concomitant malignancies other than MDS, with the exception of basocellular, spinocellular or adequately treated in situ cervical cancer,in the past 3 years;
- biological antitumor and myelosuppressive treatment within 28 days before start of study;
- bone marrow precursor cell transplantation previous to study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 10/29/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Barakaldo
- Barcelona
- Cádiz
- Palma de Mallorca
