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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

1 gm twice daily orally until end of study.

Prednisone

Intervention Type DRUG

10 mg/day orally until end of study.

Erythropoietin Beta

Intervention Type DRUG

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

Interventions

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Mycophenolate mofetil

1 gm twice daily orally until end of study.

Intervention Type DRUG

Prednisone

10 mg/day orally until end of study.

Intervention Type DRUG

Erythropoietin Beta

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

Intervention Type DRUG

Other Intervention Names

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CellCept MMF NeoRecormon

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No