Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Acute Myelogenous Leukemia Clinical Trial

Official title:

Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02802267
• Other study ID #: ICT8
• Status: Recruiting
• Phase: Phase 2
• First received: June 13, 2016
• Last updated: June 30, 2017
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Hybrigenics Corporation
• Contact: Shankar Srinivasan, PhD
• Phone: +1-2246221775
• Email: ssrinivasan[@]hybrigenics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Inecalcitol
vitamin D receptor agonist
• Placebo Oral Tablet
placebo

Locations

Country	Name	City	State
France	Necker Hospital- APHP	Paris
United States	New Mexico Cancer Care Alliance	Albuquerque	New Mexico
United States	Georgia Cancer Center-Augusta University	Augusta	Georgia
United States	Duke Cancer Institute, Duke Univ Medical Center	Durham	North Carolina
United States	University of Texas; M D Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Scripps Health	San Diego	California
United States	ProHealth Care Inc	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Hybrigenics Corporation

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		24 months