Clinical Trials /

Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

NCT02949570

Description:

To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
  • Official Title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

Clinical Trial IDs

  • ORG STUDY ID: ICT10
  • SECONDARY ID: 2014-004347-12
  • NCT ID: NCT02949570

Conditions

  • CML, Chronic Phase

Interventions

DrugSynonymsArms
InecalcitolTreatment

Purpose

To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.

Detailed Description

      To determine:

        -  Duration of response

        -  Progression free survival

        -  Proportion of responders 2 years after discontinuation of inecalcitol

        -  Duration of response after discontinuation of inecalcitol and imatinib

        -  Bone remodelling effect

        -  Safety of inecalcitol in combination with imatinib

        -  Quality of Life
    

Trial Arms

NameTypeDescriptionInterventions
TreatmentExperimental
  • Inecalcitol

Eligibility Criteria

        Inclusion Criteria:

          -  Men or women aged of at least 18 years at the time of informed consent signature;

          -  Patients have signed written informed consent;

          -  ECOG performance status < 2;

          -  Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL
             transcript positivity (e13a2 or e14a2);

          -  Treatment with imatinib for more than 2 years (a history of treatment with interferon
             is tolerated);

          -  Patient in complete cytogenetic response with BCR-ABL/ABL status between 0.1%
             International Scale (IS) and 0.01% IS and no BCR-ABL checkpoint in the last six months
             better than Molecular Response MR4 ( i.e. BCR-ABL ratio < 0.01% IS);

          -  Women of child bearing potential have a negative pregnancy test prior to first dose
             and agree to practice effective contraception during the study;

          -  Fertile men agree to practice effective contraception during the study;

          -  Patients agree to comply with the study requirements and agree to come to the clinic
             for required study visits;

          -  Patients agree to follow medication restrictions during the study;

        Exclusion Criteria:

          -  Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2);

          -  Pregnant or lactating women;

          -  Participating in another clinical trial with any investigative drug within 30 days
             prior to study enrolment(except for OPTIM imatinib);

          -  Treatment with interferon within the last 24 months;

          -  Imatinib dose modification within the last 3 months;

          -  Prior history of haematopoietic stem cell transplantation;

          -  Impaired renal function with creatinine clearance < 30 ml/min/1.73m² according to the
             MDRD formula;

          -  Hypercalcemia (corrected with albuminemia);

          -  History of diseases known to be associated with calcium disorders: ongoing
             hyperparathyroidism, sarcoidosis….;

          -  Presence or history of symptomatic kidney stones in the last 5 years;

          -  Current use of drugs known to influence serum calcium (such as thiazide diuretics,
             teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D
             or calcium);

          -  Current use of digitalis;

          -  Current use of drugs which could influence bioavailability of inecalcitol (such as
             magnesium-containing antacids, bile-resin binders);

          -  Patients with a chronic condition which is not well controlled that, according to the
             investigator, would interfere with the completion of the study;

          -  Use of any other experimental drug, therapy or vitamin D supplementation within 30
             days of first inecalcitol administration;

          -  Patients with a mental deficiency preventing proper understanding of trial protocol
             requirements;
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Measure the proportion of responders
Time Frame:12 months
Safety Issue:
Description:Proportion of responder defined as patients achieving MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABLIS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hybrigenics Corporation

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