A Phase 2 Study to Evaluate the Safety and Effectiveness of Once Weekly or Once Every Two Week Dosing of Epoetin Alfa in Anemic Patients With Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

NCT00446602 | Withdrawn Phase 2 DMC

• 1 other identifier: CR013198
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of PROCRIT (Epoetin alfa) 80,000 Units given once weekly or 80,000 Units given once every two weeks in anemic patients with Low- or Intermediate-1 risk Myelodysplastic Syndromes (MDS).

Conditions

Myelodysplastic Syndromes; Anemia

Keywords

PROCRIT; Epoetin alfa; Myelodysplastic Syndromes; MDS

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the proportion of patients (POP) in each treatment group achieving an Overall Erythroid Response (OER) [as per the 2000 International Working Group (IWG) Criteria] by Week (Wk) 13 of the study.

Secondary Outcomes (1)

• Proportion of patients (POP) w/OER by Wk 24 & study end; time and duration of OER; POP w/OER by Wk 13 & 24 (2006 IWG criteria);time to achieve Hb 11 g/dL; score change of BFI & SF-36 from baseline to study end;POP remaining RBC-transfusion free by Wk 24

Study Arms (1)

001

EXPERIMENTAL

Epoetin alfa Type=exact unit=units number=80 000 form=solution for injection route=subcutaneous use once every week or once every 2 weeks.

Drug: Epoetin alfa

Interventions

Epoetin alfa DRUG

Type=exact, unit=units, number=80,000, form=solution for injection, route=subcutaneous use, once every week or once every 2 weeks.

001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Myelodysplastic Syndromes (MDS) via bone marrow aspirate and biopsy according to World Health Organization (WHO) Criteria or French-American-British (FAB) Classification. All WHO and FAB subtypes of MDS are potentially eligible, provided the subject's International Prognostic Scoring System (IPSS) score is Low- or Intermediate-1 \[with the exception of chronic myelomonocytic leukemia (CMML)\]
• Documentation of IPSS score of Low- or Intermediate-1 risk disease (\<= 10% bone marrow blasts), based on bone marrow aspirate, biopsy, and cytogenetics, within 12 weeks prior to study entry
• Baseline hemoglobin (Hb) value of \<10 g/dL \[defined as the average of at least 2 measurements \[(not influenced by red blood cell (RBC) transfusions for at least 1 week) \>= 1 week apart\]. The Hb level prior to the first dose of PROCRIT (Epoetin alfa) cannot be \> 10.5 g/dL.

You may not qualify if:

• No anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding)
• No proliferative (White Blood Cells (WBC) \>= 12,000/mm3) chronic myelomonocytic leukemia (CMML)
• No history of (within 6 months) cerebrovascular accident \[(CVA), includes ischemic, embolic and hemorrhagic\], transient ischemic attack (TIA), myocardial ischemia \[includes Unstable Angina, Q wave Myocardial Infarction (QwMI) and non-Q wave Myocardial Infarction (NQMI)\], or other arterial thrombosis
• No prior Erythropoietin Receptor Agonist (ERA) treatment within 4 weeks prior to the first study dose
• No prior ERA treatment failure (defined as having shown no Hb response or a Hb response \<1 g/dL after at least 6 weeks of ERA treatment) with minimum dose of Epoetin alfa 40,000 Units/week or Darbepoetin alfa 150 mcg/ week.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Completion: August 1, 2009
• Last Updated: September 20, 2016

Record last verified: 2011-06