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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171223

Purpose

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

Condition	Intervention	Phase
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia	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 Adult Patients With Ph + Leukemia

Further study details as provided by Novartis:

Primary Outcome Measures:

To decrease the frequency of bone marrow evaluations
To enable patients to continue to have access to study treatment

Secondary Outcome Measures:

No secondary outcomes/objectives planned

Estimated Enrollment:	307
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria

Successful completion of the CSTI571A 0110 E1 study
Written informed consent for the extension CSTI571A0110E2

Exclusion Criteria

none

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171223

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSTI571A0110E2
Study First Received:	September 12, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00171223
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Chronic Myelogenous Leukemia
CML
Philadelphia Chromosome
Accelerated phase
Acute Myelogenous Leukemia

AML
Acute Lymphoblastic Leukemia
ALL
Imatinib mesylate

Study placed in the following topic categories:

Philadelphia Chromosome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Chronic myelogenous leukemia
Hematologic Diseases
Acute myelogenous leukemia
Myeloproliferative Disorders
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Imatinib
Leukemia
Lymphatic Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Bone Marrow Diseases
Acute myelocytic leukemia
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009