Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
- Registration Number
- NCT02949570
- Lead Sponsor
- Hybrigenics Corporation
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Inecalcitol -
- Primary Outcome Measures
Name Time Method Measure the proportion of responders 12 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Côte de Nacre
🇫🇷Caen, France