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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

September 6, 2007

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00171223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

No secondary outcomes/objectives planned

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Intervention ^†

Drug: imatinib mesylate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

307

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171223

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.