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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171158

Purpose

This extension II study will allow for further follow-up of the disease under treatment with imatinib mesylate and allow the patients to continue to receive imatinib mesylate.

Condition	Intervention	Phase
Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis	Drug: imatinib mesylate	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

No secondary outcomes/objectives planned

Estimated Enrollment:	8
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171158

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSTI571A0102E2
Study First Received:	September 12, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00171158
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Chronic Myelogenous Leukemia
CML
Philadelphia Chromosome
Blast crisis
Imatinib mesylate

Study placed in the following topic categories:

Imatinib
Philadelphia Chromosome
Blast Crisis
Leukemia
Chronic myelogenous leukemia

Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on January 16, 2009