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

NCT01827930 | Terminated Phase 3 Results DMC

• 2 other identifiers: IB2009-072008-007094-20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia, Myeloid, Chronic-Phase

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study

  The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.

  12 months

Secondary Outcomes (7)

• Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study

  3, 6, 9 and 12 months

• Molecular Response at 3, 6, 9 and 12 Months

  3, 6, 9 and 12 months

• Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)

  From date of randomization until the date of complete molecular response (up to 12 months)

• Rate of BCR-ABL Undetectable

  12 first months

• Time to the First BCR-ABL Undetectable

  within 12 months following randomization

Study Arms (3)

Imatinib 600 (Randomized trial)

EXPERIMENTAL

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

Drug: Imatinib Mesylate 600 MG Oral Tablet

Imatinib 400 (Randomized trial)

ACTIVE COMPARATOR

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

Drug: Imatinib Mesylate 400 MG Oral Tablet

Imatinib400 (Cohort)

OTHER

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

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate 600 MG Oral Tablet DRUG

Imatinib Mesylate for CP CML

Also known as: GLIVEC

Imatinib 600 (Randomized trial)

Imatinib Mesylate 400 MG Oral Tablet DRUG

Imatinib Mesylate for CP CML

Also known as: GLIVEC

Imatinib 400 (Randomized trial)

Imatinib Mesylate DRUG

Imatinib Mesylate for CP CML

Also known as: GLIVEC

Imatinib400 (Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead
• Novartis: collaborator

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

Related Links

• Registre des essais cliniques de l'INCa
• Site internet du promoteur, l'Institut Bergonié

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Imatinib Mesylate; Tablets

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Pr Simone Mathoulin-Pelissier
• Organization: Institut Bergonié

S.Mathoulin@bordeaux.unicancer.fr

05 56 33 33 33

Study Officials

• ETIENNE Gabriel, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: IM concentration \< 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration \>= 1000ng/mL Parallel Cohort: "standard strategy"

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: April 10, 2013
• Study Start: July 1, 2009
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Locations

FR (1)