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Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response

NCT ID: NCT01827930

Last Updated: 2020-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2017-01-01

Brief Summary

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The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

Detailed Description

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The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.

Conditions

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Leukemia, Myeloid, Chronic-Phase

Keywords

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chronic myeloid leukemia in chronic phase residual plasma IM concentration adapted strategy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

IM concentration \< 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration \>= 1000ng/mL Parallel Cohort: "standard strategy"
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib 600 (Randomized trial)

Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po

Group Type EXPERIMENTAL

Imatinib Mesylate 600 MG Oral Tablet

Intervention Type DRUG

Imatinib Mesylate for CP CML

Imatinib 400 (Randomized trial)

Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Group Type ACTIVE_COMPARATOR

Imatinib Mesylate 400 MG Oral Tablet

Intervention Type DRUG

Imatinib Mesylate for CP CML

Imatinib400 (Cohort)

Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Group Type OTHER

Imatinib Mesylate

Intervention Type DRUG

Imatinib Mesylate for CP CML

Interventions

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Imatinib Mesylate 600 MG Oral Tablet

Imatinib Mesylate for CP CML

Intervention Type DRUG

Imatinib Mesylate 400 MG Oral Tablet

Imatinib Mesylate for CP CML

Intervention Type DRUG

Imatinib Mesylate

Imatinib Mesylate for CP CML

Intervention Type DRUG

Other Intervention Names

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GLIVEC GLIVEC GLIVEC

Eligibility Criteria

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Inclusion Criteria

1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
2. Patients in complete cytogenetic response for at least 1 year
3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
4. ECOG ≤ 2,
5. Age ≥ 18 years
6. Signed informed consent,
7. Membership of a social security system

Exclusion Criteria

1. Patients with CML-CP Philadelphia chromosome negative diagnosis.
2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
5. Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
6. Known HIV positive
7. Patients previously treated with another tyrosine kinase inhibitor
8. Patient participating in another interventional clinical trial
9. History of non-compliance to Imatinib Mesylate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ETIENNE Gabriel, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

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Institut Bergonié

Bordeaux, Aquitaine, France

Site Status

Countries

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France

Related Links

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https://www.e-cancer.fr/Professionnels-de-sante/Le-registre-des-essais-cliniques

Registre des essais cliniques de l'INCa

https://www.bergonie.fr/les-essais-cliniques

Site internet du promoteur, l'Institut Bergonié

Other Identifiers

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2008-007094-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IB2009-07

Identifier Type: -

Identifier Source: org_study_id