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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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

Find a Location

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Mar 2025