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An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

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Trial Information

An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis


Inclusion Criteria:



- Successful completion of the CSTI571A0102E1 study

- Written informed consent for the extension CSTI571A0102E2

Exclusion Criteria:

- none

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To enable patients to have access to study drug and continue treatment

Outcome Time Frame:

until no patients are left on study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571A0102E2

NCT ID:

NCT00171158

Start Date:

August 2004

Completion Date:

April 2014

Related Keywords:

  • Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis
  • Chronic Myelogenous Leukemia
  • CML
  • Philadelphia Chromosome
  • Blast crisis
  • Imatinib mesylate
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of North CarolinaChapel Hill, North Carolina  27599
University of ChicagoChicago, Illinois  60637
UCLALos Angeles, California  90095
Johns Hopkins HospitalBaltimore, Maryland  21287
Dana Faber InstituteBoston, Massachusetts  02115
Wayne State University/Kamanos Cancer CenterDetroit, Michigan  48201