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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided by Poitiers University Hospital

Additional 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
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:
CML
Acute Phase
Imatinib mesylate
Cytarabine
Daunorubicine

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

ClinicalTrials.gov processed this record on August 21, 2014