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Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219765
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, France
Novartis
Information provided by:
Poitiers University Hospital
  Purpose
The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

Condition Intervention Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 600 mg Drug: Cytarabine Drug: Daunorubicine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine

Secondary Outcome Measures:
  • - To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
  • - To evaluate duration of responses and failure to respond

Estimated Enrollment: 30
Study Start Date: May 2001
Estimated Study Completion Date: January 2006
Detailed Description:

Study design Imatinib: starting at day –3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels

level 1: 0

level 2: 15mg/m² ; 3 days

level 3: 30mg/m² ; 3 days

level 4: 45mg/m² ; 3 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CML Ph+ (assessed by cytogenetic or FISH)
  • Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)
  • Age ≥ 18 year at inclusion
  • PS grade 0 to 2 (ECOG)
  • Adequate and organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
  • Informed consent signed up

Exclusion Criteria:

  • active malignancy other than CML or non-melanoma cancer of the skin
  • current treatment with another investigational agent
  • patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.
  • patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
  • patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219765


Locations
France
University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Ministry of Health, France
Novartis
Investigators
Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00219765     History of Changes
Other Study ID Numbers: 010495
CSTI571AFR01
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Poitiers University Hospital:
CML
Acute Phase
Imatinib mesylate
Cytarabine
Daunorubicine

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cytarabine
Imatinib Mesylate
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors