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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00219765

Collaborator

Ministry of Health, France (Other), Novartis (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Drug: Imatinib mesylate 600 mg Drug: Cytarabine Drug: Daunorubicine	Phase 1/Phase 2

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

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

May 1, 2001

Study Completion Date :

Jan 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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