Clinical trial NCT02802267: Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Official title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Lead sponsor: Hybrigenics Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.


Eligibility criteria: Inclusion Criteria:

• Patients aged 65 to \< 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy.

or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;

• Newly diagnosed, untreated de novo or secondary AML according to WHO classification;

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;
* 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;
* Chronic myelogenous or acute promyelocytic leukaemia;
* Known CNS involvement;
* Patient eligible to bone marrow or stem cell transplant;
* WBC ≥ 30.000/mm3;
* Impaired renal function with Creatinine clearance \< 30 mL/min/1.73m² according to the MDRD formula;
* Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal value);
* Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (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;
* Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or to the excipient of inecalcitol tablets (lactose);
* 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);
* 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;

Primary outcomes:
measure: overall survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
city: Augusta
country: United States
facility: Georgia Cancer Center-Augusta University
state: Georgia
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance
state: New Mexico
city: Durham
country: United States
facility: Duke Cancer Institute, Duke Univ Medical Center
state: North Carolina
city: Houston
country: United States
facility: University of Texas; M D Anderson Cancer Center
state: Texas
city: Waukesha
country: United States
facility: ProHealth Care Inc
state: Wisconsin
city: Paris
country: France
facility: Necker Hospital- APHP
Study officials:
affiliation: Hybrigenics Corporation
name: Jean-Francois Dufour-Lamartinie, MD
role: PRINCIPAL_INVESTIGATOR
References: