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

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

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

Study Overview

• Status: Unknown
• Conditions: CML, Chronic Phase
• Intervention / Treatment: Drug: Inecalcitol

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 Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • CHU côte de Nacre
    • Contact: Hyacinthe Johnson- Ansah, MD; Phone Number: +33-2-31-27-25-39; Email: johnsonansah-a@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the proportion of responders	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.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: ICT10; 2014-004347-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO