Residual disease in Chronic Myeloid Leukaemia MedDRA version: 18.0 Level: LLT Classification code 10009015 Term: Chronic myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: inecalcitol
Product Code: HBX 34,701
Pharmaceutical Form: Tablet
INN or Proposed INN: inecalcitol
CAS Number: 163217-09-2
Current Sponsor code: HBX 34,701
Other descriptive name: TX522
C
Sponsors
Hybrigenics SA
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
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 from 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 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of inecalcitol in combination with imatinib in chronic myeloid leukaemia patients with molecular residual disease on imatinib monotherapy.;Secondary Objective: To determine: - duration of response - progression free survival - proportion of responders during inecalcitol treatment and 2 years after discontinuation of inecalcitol and imatinib - bone remodeling effect - safety of inecalcitol in combination with imatinib - quality of life;Primary end point(s): Proportion of responders defined as patients achieving at least MR4.5 (i.e. detectable disease = 0.0032 % BCR-ABL IS or undetectable disease with cDNA with =32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.;Timepoint(s) of evaluation of this end point: At 6 months and then at least every 3 months or every month for patient achieving MR4,5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Efficacy : at 6 months and every 3 months afterwards - Safety : continuously from informed consent form signature and up to 4 weeks after the last IMP intake.;Secondary end point(s): - Efficacy: • Duration of the response evaluated by BCR-ABL/ABL ratio; • Progression free survival defined as the time from the date of first inecalcitol treatment dose until the date of the first documentation of progressive disease or death; • Proportion of responders 2 years after inecalcitol discontinuation evaluated by BCR-ABL/ABL ratio; • Duration of response after inecalcitol and imatinib discontinuation evaluated by BCR-ABL/ABL ratio performed every 3 months; • Bone remodeling by measurement of C-telopeptide, osteocalcin, calcitonin and PTH every 3 months during inecalcitol treatment period; • Quality of life evaluated by EORTC QLQ-CX24 questionnaire every 6 months during the study; - Safety: • Incidence and characteristics of all AE(s) and SAE(s) from clinical and laboratory assessment according to the NCI/CTC AE version 4.0 scale; • Incidence, severity, duration and time to occurrence of hypercalcemia; | — |
Countries
France
Contacts
Public ContactJean-François Dufour-Lamartinie
Hybrigenics SA
Outcome results
None listed