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

Myelodysplastic Syndromes Clinical Trial

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.¿

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551291
• Other study ID #: ML20559
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2007
• Last updated: March 1, 2016
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete remission (transfusions, hematology parameters, bone marrow aspirates)		Week 12	No
Primary	Cytogenesis assessments of bone marrow		Weeks 24 and 52	No
Secondary	AEs, laboratory parameters, vital signs.		Throughout study	No