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Therapeutic Areas: Oncology | Hematology
Disease Category: Myelodysplastic Syndromes (MDS)
Trial Information
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
Status: Completed
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 Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Single Group
- Endpoints: Safety/Efficacy
Study Type:
Interventional
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
Accepts Healthy Volunteers: No
Trial Registration Date: 10/29/2007
Date Last Updated: 09/16/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Barakaldo 48903
Spain
Phone: 888-662-6728 (U.S. Only)
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