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Vitamin D Analogue

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

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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
~12 spots leftby Dec 2025
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