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

Original Primary Outcome Measures ^†

Efficacy
Response

Change History

Complete list of historical versions of study NCT00171158 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 Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis

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

Brief Summary

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.

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 Myeloid Blast Crisis

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 ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171158

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.