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

This study has been terminated.
Ministry of Health, France
Information provided by:
Poitiers University Hospital Identifier:
First received: September 13, 2005
Last updated: November 25, 2005
Last verified: September 2005
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 identifier: NCT00219765

University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Ministry of Health, France
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 Identifier (NCT Number): Identifier: NCT00219765     History of Changes
Other Study ID Numbers: 010495  CSTI571AFR01 
Study First Received: September 13, 2005
Last Updated: November 25, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Poitiers University Hospital:
Acute Phase
Imatinib mesylate

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid
Myeloproliferative Disorders
Neoplasms by Histologic Type
Imatinib Mesylate
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on May 26, 2016