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

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ClinicalTrials.gov Identifier: NCT00551291
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : June 23, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 (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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Mycophenolate mofetil Drug: Prednisone Drug: Erythropoietin Beta Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.¿
Study Start Date : August 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Drug: Mycophenolate mofetil
1 gm twice daily orally until end of study.
Other Names:
  • CellCept
  • MMF

Drug: Prednisone
10 mg/day orally until end of study.

Drug: Erythropoietin Beta
Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
Other Name: NeoRecormon




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551291


Locations
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Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08003
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Cádiz, Spain, 11009
Madrid, Spain, 28040
Palma de Mallorca, Spain, 07198
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00551291     History of Changes
Other Study ID Numbers: ML20559
First Posted: October 30, 2007    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: July 25, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Mycophenolic Acid
Prednisone
Epoetin Alfa
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics