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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 University Portland, Oregon  97201
New York Presbyterian Hospital New York, New York  10021
Dana Faber Cancer Institute Boston, Massachusetts  02115
MD Anderson Cancer Center, University of Texas Houston, Texas  77030