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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171249
First received: September 12, 2005
Last updated: March 21, 2014
Last verified: March 2014
  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 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:


Further study details as provided by Novartis:

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

Enrollment: 57
Study Start Date: August 2004
Study Completion Date: September 2013
Primary Completion Date: September 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 CSTI571A0109E1 study
  • Written informed consent for the extension CSTI571A0109E2

Exclusion Criteria:

- none

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171249

Locations
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77030
France
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Poitiers, France
Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Mannheim, Germany
Italy
Novartis Investigative Site
Monza, Italy
United Kingdom
Novartis Investigative Site
London, United Kingdom
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: NCT00171249     History of Changes
Other Study ID Numbers: CSTI571A0109E2
Study First Received: September 12, 2005
Last Updated: March 21, 2014
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 July 23, 2014