Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years

NCT00219752 | Completed Phase 2

• 2 other identifiers: 020948CSTI571AFR04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia

Keywords

CML - ederly patients - Imatinib mesylate

Outcome Measures

Primary Outcomes (2)

• Tolerability

• Quality of life

Secondary Outcomes (5)

• . 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

Interventions

Imatinib mesylate 400 mg DRUG

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• CML Ph+ (assessed by cytogenetic or FISH)
• Chronic phase with less than 5% bone marrow blasts
• Diagnosis within 12 months
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Novartis: collaborator

Study Sites (1)

University Hospital

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• François GUILHOT, MD

  Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

  STUDY CHAIR

• Philippe ROUSSELOT, MD

  Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2002
• Study Completion: May 1, 2007
• Last Updated: December 22, 2005

Record last verified: 2005-09

Locations

FR (1)