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

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219765
• Other study ID #: 010495
• Secondary ID: CSTI571AFR01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: November 25, 2005
• Start date: May 2001
• Est. completion date: January 2006

Study information

• Verified date: September 2005
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Imatinib mesylate 600 mg

• Cytarabine

• Daunorubicine

Locations

Country	Name	City	State
France	University Hospital	Poitiers

Sponsors (3)

Lead Sponsor	Collaborator
Poitiers University Hospital	Ministry of Health, France, Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
Secondary	- To evaluate duration of responses and failure to respond

External Links

•   French CML Group (FI-LMC) web-site