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Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study (ICT10)

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ClinicalTrials.gov Identifier: NCT02949570
Recruitment Status : Unknown
Verified October 2016 by Hybrigenics Corporation.
Recruitment status was:  Recruiting
First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hybrigenics Corporation

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

Condition or disease Intervention/treatment Phase
CML, Chronic Phase Drug: Inecalcitol Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
Study Start Date : February 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Treatment Drug: Inecalcitol
Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.




Primary Outcome Measures :
  1. Measure the proportion of responders [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949570


Contacts
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Contact: Jean-Francois Dufour-Lamartinie, MD +33-158103805 jfdufour@hybrigenics.com

Locations
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France
CHU Côte de Nacre Recruiting
Caen, France, 14033
Contact: Hyacinthe Johnson- Ansah, MD    +33-2-31-27-25-39    johnsonansah-a@chu-caen.fr   
Sponsors and Collaborators
Hybrigenics Corporation
Investigators
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Study Director: Jean-Francois Dufour-Lamartinie, MD Hybrigenics
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Responsible Party: Hybrigenics Corporation
ClinicalTrials.gov Identifier: NCT02949570    
Other Study ID Numbers: ICT10
2014-004347-12 ( EudraCT Number )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases