Acute Myeloid Leukemia MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000012984
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: TX522
Other descriptive name: INECALCITOL
Sponsors
Hybrigenics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients aged 65 to =65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: •Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization; •Prior treatment with decitabine, azacitidine, or cytarabine; •Chronic myelogenous or acute promyelocytic leukaemia; •Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma « in situ » of the cervix or breast; •Known CNS involvement; •Patient eligible to bone marrow or stem cell transplant; •WBC = 30.000/mm3; •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); •Use of any other experimental drug or therapy or vitamin D supplementation within 4 weeks of randomization; •Known HIV; •Patients who are eligible for intensive induction therapy with curative intent; •Refractory congestive heart failure; •Active infection resistant to anti-infective therapy; •Documented pulmonary disease with DLCO = 65% or FEV1 = 65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm; • Liver cirrhosis Child B or C or acute viral hepatitis; • Current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or current cognitive status that produces dependence (as confirmed by the specialist) not controlled by the caregiver; • Uncontrolled neoplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.;Secondary Objective: To evaluate: - Complete response - Event-free and relapse-free survival between treatment arms - Incidence and severity of toxicities - Incidence of infectious episodes;Primary end point(s): Overall survival defined as the time from randomization to the date of death for any cause;Timepoint(s) of evaluation of this end point: Each time during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Proportion of patients who obtain composite CR according to IWG 2003 recommendations including CRi/CRp; - Event-free survival defined as the time from the date of randomization to the date of treatment failure, relapse or death from any cause, whichever occurs first. - Relapse-free survival is defined only for patients achieving a complete remission. It is defined as the interval from the date of first documentation of leukemia-free state to the date of treatment failure, relapse or death from any cause whichever occurs first 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.;Timepoint(s) of evaluation of this end point: - Efficacy : after 3 and 6 cycles of treatment - Safety : continuously from informed consent form signature and up to 4 weeks after the last IMP intake. | — |
Countries
Belgium, France, Germany, Spain, United States
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic
Outcome results
None listed