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

CML, Chronic Phase Clinical Trial

— ICT10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02949570
• Other study ID #: ICT10
• Secondary ID: 2014-004347-12
• Status: Recruiting
• Phase: Phase 2
• First received: October 27, 2016
• Last updated: October 27, 2016
• Start date: February 2014
• Est. completion date: April 2018

Study information

• Verified date: October 2016
• Source: Hybrigenics Corporation
• Contact: Jean-Francois Dufour-Lamartinie, MD
• Phone: +33-158103805
• Email: jfdufour[@]hybrigenics.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CML, Chronic Phase
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

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.

Locations

Country	Name	City	State
France	CHU Côte de Nacre	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Hybrigenics Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No