Text Size

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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171223
First received: September 12, 2005
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To enable patients to continue to have access to study treatment [ Time Frame: December 31, 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 307
Study Start Date: August 2004
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gleevec/Glivec Drug: imatinib mesylate

  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 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

  Show 27 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171223     History of Changes
Other Study ID Numbers: CSTI571A0110E2
Study First Received: September 12, 2005
Last Updated: April 23, 2013
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013