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

This study has been terminated.
Sponsor:
Collaborators:
Ministry of Health, France
Novartis
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00219765
First received: September 13, 2005
Last updated: November 25, 2005
Last verified: September 2005

September 13, 2005
November 25, 2005
May 2001
Not Provided
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
Same as current
Complete list of historical versions of study NCT00219765 on ClinicalTrials.gov Archive Site
  • - 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
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

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.

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

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myeloid Leukemia
  • Drug: Imatinib mesylate 600 mg
  • Drug: Cytarabine
  • Drug: Daunorubicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
January 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00219765
010495, CSTI571AFR01
Not Provided
Not Provided
Poitiers University Hospital
  • Ministry of Health, France
  • Novartis
Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Poitiers University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP