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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.¿


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

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.¿


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of complete remission (transfusions, hematology parameters, bone marrow aspirates)

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agency for Medicines and Medical Devices

Study ID:

ML20559

NCT ID:

NCT00551291

Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

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