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

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. Identifier: NCT00219765
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : November 28, 2005
Ministry of Health, France
Information provided by:
Poitiers University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 600 mg Drug: Cytarabine Drug: Daunorubicine Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : May 2001
Study Completion Date : January 2006

Primary Outcome Measures :
  1. 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 :
  1. - To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
  2. - To evaluate duration of responses and failure to respond

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00219765

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University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Ministry of Health, France
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Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00219765    
Other Study ID Numbers: 010495
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 28, 2005
Last Verified: September 2005
Keywords provided by Poitiers University Hospital:
Acute Phase
Imatinib mesylate
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antimetabolites, Antineoplastic
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