Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years - Full Text View

Sponsors and Collaborators:	Poitiers University Hospital Novartis
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00219752

Purpose

The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.

Condition	Intervention	Phase
Chronic Myeloid Leukemia	Drug: Imatinib mesylate 400 mg	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year

Resource links provided by NLM:

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:

Tolerability
Quality of life

Secondary Outcome Measures:

. the survival without progression
. the survival without event
. the overall survival
. the hematologic cytogenetic and molecular responses at various check points.
. duration of responses and failure to respond

Estimated Enrollment:	30
Study Start Date:	May 2002
Estimated Study Completion Date:	May 2007

Detailed Description:

Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.

Duration of responses and failure to respond will be evaluated.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CML Ph+ (assessed by cytogenetic or FISH)
Chronic phase with less than 5% bone marrow blasts
Diagnosis within 12 months
Age ≥ 70 year at inclusion
PS grade 0 to 2 (ECOG)
Mini mental status more than 25
Hydroxyurea optional before Imatinib
Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.

Exclusion Criteria:

patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
Mini mental status ≤ 25
patients who are not able to adequately take the study drug
Age less than 70 y
accelerated or blastic phase
previous therapy with imatinib or interferon
HIV positivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219752

Locations

France
University Hospital
Poitiers, France, 86021

Sponsors and Collaborators

Poitiers University Hospital

Novartis

Investigators

Study Chair:	François GUILHOT, MD	Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Principal Investigator:	Philippe ROUSSELOT, MD	Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)

More Information

Additional Information:

French CML Group (FI-LMC) web-site This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	020948, CSTI571AFR04
Study First Received:	September 13, 2005
Last Updated:	December 21, 2005
ClinicalTrials.gov Identifier:	NCT00219752 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

CML - ederly patients - Imatinib mesylate

Study placed in the following topic categories:

Imatinib
Leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Myelogenous Leukemia
Leukemia, Myeloid
Bone Marrow Diseases
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors

Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 01, 2009