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

Sponsors and Collaborators:	Poitiers University Hospital Ministry of Health, France Novartis
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00219765

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Imatinib Imatinib mesylate Cytarabine

U.S. FDA Resources

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

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:

French CML Group (FI-LMC) web-site This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	010495, CSTI571AFR01
Study First Received:	September 13, 2005
Last Updated:	November 25, 2005
ClinicalTrials.gov Identifier:	NCT00219765 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

CML
Acute Phase
Imatinib mesylate
Cytarabine
Daunorubicine

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Protein Kinase Inhibitors
Antiviral Agents

Immunosuppressive Agents
Imatinib
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Bone Marrow Diseases
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Physiological Effects of Drugs
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid

Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Cytarabine

ClinicalTrials.gov processed this record on September 01, 2009