Overview

A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.

Status:
Completed

Trial end date:
2009-06-01

Target enrollment:
0

Participant gender:
All

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 (30000 IU/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 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Epoetin Alfa
Mycophenolate mofetil
Mycophenolic Acid
Prednisone

Criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- diagnosis of MDS, according to International Prognostic Scoring System (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.