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Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

NCT00375219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2021-11-15

Study results available
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Summary

To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Omacetaxine mepesuccinate

Induction: 1.25 mg/m\^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study. Maintenance: 1.25 mg/m\^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years.

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • ChemGenex Pharmaceuticals

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Jorge Cortes, MD · Univ. of Texas M.D. Anderson Cancer Center

  • Andreas Hochhaus, MD Prof Dr · Mannheim der Universitat Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-20
Primary Completion
2010-03-23
Completion
2013-06-28

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Poland
  • Singapore
  • United Kingdom

Study Locations

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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 NCT00375219 on ClinicalTrials.gov