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

NCT02949570 | Unknown Phase 2 DMC

• 2 other identifiers: ICT102014-004347-12
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CML, Chronic Phase

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Inecalcitol

Interventions

Inecalcitol DRUG

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hybrigenics Corporation: lead

Study Sites (1)

CHU Côte de Nacre

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

inecalcitol

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Francois Dufour-Lamartinie, MD

  Hybrigenics

  STUDY DIRECTOR

Central Study Contacts

Jean-Francois Dufour-Lamartinie, MD

CONTACT

+33-158103805; jfdufour@hybrigenics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 31, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)