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

Sponsor
Hybrigenics Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02949570
Collaborator
(none)
54
Enrollment
1
Location
1
Arm
49.9
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Measure the proportion of responders [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Côte de Nacre Caen France 14033

Sponsors and Collaborators

  • Hybrigenics Corporation

Investigators

  • Study Director: Jean-Francois Dufour-Lamartinie, MD, Hybrigenics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hybrigenics Corporation
ClinicalTrials.gov Identifier:
NCT02949570
Other Study ID Numbers:
  • ICT10
  • 2014-004347-12
First Posted:
Oct 31, 2016
Last Update Posted:
Oct 31, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase

Study Results

No Results Posted as of Oct 31, 2016