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An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

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Trial Information

An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia


Inclusion Criteria:



- Successful completion of the CSTI571A0109E1 study

- Written informed consent for the extension CSTI571A0109E2

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 study treatment

Outcome Time Frame:

December 31, 2011

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571A0109E2

NCT ID:

NCT00171249

Start Date:

August 2004

Completion Date:

April 2013

Related Keywords:

  • Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • CML
  • Philadelphia Chromosome
  • Accelerated phase
  • Acute Myelogenous Leukemia
  • AML
  • Acute Lymphoblastic Leukemia
  • ALL
  • Imatinib mesylate
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Oregon Health & Sciences UniversityPortland, Oregon  97201
New York Presbyterian HospitalNew York, New York  10021
Dana Faber Cancer InstituteBoston, Massachusetts  02115
MD Anderson Cancer Center, University of TexasHouston, Texas  77030