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Vitamin D Analogue
inecalcitol for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Jean-Francois Dufour-Lamartinie, MD
Research Sponsored by Hybrigenics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
• 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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.
Eligible Conditions
- Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall survival
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: inecalcitolExperimental Treatment1 Intervention
Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.
Group II: placeboPlacebo Group1 Intervention
Two tablets of placebo 2mg each (total 4mg) taken orally every other day
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Who is running the clinical trial?
Hybrigenics CorporationLead Sponsor
1 Previous Clinical Trials
54 Total Patients Enrolled
Jean-Francois Dufour-Lamartinie, MDPrincipal InvestigatorHybrigenics Corporation
1 Previous Clinical Trials
54 Total Patients Enrolled
Frequently Asked Questions
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