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

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hybrigenics Corporation
• Treatments: Cholecalciferol; Imatinib Mesylate

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;