CML, Chronic Phase Clinical Trial
— ICT10Official title:
Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | April 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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; |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Côte de Nacre | Caen |
Lead Sponsor | Collaborator |
---|---|
Hybrigenics Corporation |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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