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

NCT00551291 | Completed Phase 2 Results

• 1 other identifier: ML20559
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

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.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 2 years

• Mean Number of Blood Transfusions Per Visit

  Up to approximately 2 years

Secondary Outcomes (1)

• Percentage of Participants With at Least One Adverse Event (AE)

  Up to approximately 2 years

Study Arms (1)

Mycophenolate Mofetil + Prednisone + Erythropoietin Beta

EXPERIMENTAL

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; Drug: Prednisone; Drug: Erythropoietin Beta

Interventions

Mycophenolate mofetil DRUG

1 gm twice daily orally until end of study.

Also known as: CellCept, MMF

Mycophenolate Mofetil + Prednisone + Erythropoietin Beta

Prednisone DRUG

10 mg/day orally until end of study.

Mycophenolate Mofetil + Prednisone + Erythropoietin Beta

Erythropoietin Beta DRUG

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

Also known as: NeoRecormon

Mycophenolate Mofetil + Prednisone + Erythropoietin Beta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Barakaldo, 48903, Spain

Location

Unknown Facility

Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Cadiz, 11009, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Palma de Mallorca, 07198, Spain

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Mycophenolic Acid; Prednisone; epoetin beta

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 25, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-06

Locations

ES (8)