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

Hybrigenics

Status and phase

Unknown

Phase 2

Conditions

CML, Chronic Phase

Treatments

Drug: Inecalcitol

Study type

Interventional

Funder types

Industry

Identifiers

2014-004347-12 (EudraCT Number)

ICT10

Details and patient eligibility

About

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

Full description

To determine:

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;