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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00551291

Purpose

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

Condition	Intervention	Phase
Myelodysplastic Syndromes	Drug: epoetin beta [NeoRecormon] Drug: CellCept Drug: Prednisone	Phase II

Drug Information available for: Prednisone Epoetin alfa Erythropoietin Epoetin beta Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.'

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Incidence of complete remission (transfusions, hematology parameters, bone marrow aspirates) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Cytogenesis assessments of bone marrow [ Time Frame: Weeks 24 and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1: Experimental	Drug: epoetin beta [NeoRecormon] 30,000IU sc/week (starting dose) Drug: CellCept 1g po twice daily Drug: Prednisone As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551291

Locations

Spain

Barcelona, Spain, 08036

Cádiz, Spain, 11009

MADRID, Spain, 28040

BARCELONA, Spain, 08035

BARCELONA, Spain, 08025

BARCELONA, Spain, 08003

PALMA DE MALLORCA, Spain, 07198

BARAKALDO, Spain, 48903

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20559
Study First Received:	October 29, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00551291
Health Authority:	Spain: Agency for Medicines and Medical Devices

Study placed in the following topic categories:

Epoetin Alfa
Myelodysplastic syndromes
Prednisone
Preleukemia
Precancerous Conditions

Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Mycophenolate mofetil
Bone Marrow Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009