Back to resultsA Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Mycophenolate mofetil
Prednisone
Erythropoietin Beta
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
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.
Mean Number of Blood Transfusions Per Visit
Secondary Outcome Measures
Percentage of Participants With at Least One Adverse Event (AE)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551291
Brief Title
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
CellCept, MMF
Intervention Description
1 gm twice daily orally until end of study.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
10 mg/day orally until end of study.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin Beta
Other Intervention Name(s)
NeoRecormon
Intervention Description
Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
Description
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.
Time Frame
Up to approximately 2 years
Title
Mean Number of Blood Transfusions Per Visit
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least One Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
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