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Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes

NCT00379912 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-02-14

Study results available
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Summary

This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed to influence the differentiation of primitive hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood cells for patients in whom inadequate production of red blood cells is the major clinical issue.

Conditions

Interventions

DRUG

Azacitidine

Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.

DRUG

Erythropoietin

Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy

DRUG

Azacitidine (Monotherapy)

Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Ortho Biotech Clinical Affairs, L.L.C.

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Larry Cripe, MD

    lead OTHER

Principal Investigators

  • Larry Cripe, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379912 on ClinicalTrials.gov