Clinical trial NCT02949570: Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
Official title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: CML, Chronic Phase
Lead sponsor: Hybrigenics Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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;

Primary outcomes:
measure: Measure the proportion of responders
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Côte de Nacre
Study officials:
affiliation: Hybrigenics
name: Jean-Francois Dufour-Lamartinie, MD
role: STUDY_DIRECTOR
References: