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Completed

NCT Number: NCT00551291

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

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.

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barakaldo, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolate mofetil

Drug

1 gm twice daily orally until end of study.

Other names: CellCept, MMF

Prednisone

Drug

10 mg/day orally until end of study.

Erythropoietin beta

Drug

Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.

Other names: NeoRecormon

Primary outcomes

  1. Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement

    Time frame: Up to approximately 2 years

    International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.

  2. Mean Number of Blood Transfusions Per Visit

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Percentage of Participants With at Least One Adverse Event (AE)

    Time frame: Up to approximately 2 years

    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.¿

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2007
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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