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Flavonoid
Quercetin for Fanconi Anemia
Phase 1
Waitlist Available
Led By Parinda Mehta, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to treat people with Fanconi anemia, which is a disease that causes bone marrow failure and other problems.
Eligible Conditions
- Fanconi Anemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Quercetin - Dietary SupplementExperimental Treatment1 Intervention
Quercetin will be given orally on a twice a day schedule starting with weight adjusted dose for a maximum total daily dose of 1500 mg/day, for 4 months (16 weeks). Pharmacokinetics (PK) data will be analyzed after each cohort of 3 patients and will be used to optimize the dosing schedule (if required) for subsequent patients.
An expansion cohort has been added to the study protocol. Up to 20 patients may be enrolled. The dose utilized will be the same as the max weight adjusted dose that showed biological activity in our last cohort of patients (subjects #10-12 from above).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quercetin (dietary supplement)
2012
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,573 Total Patients Enrolled
9 Trials studying Fanconi Anemia
223 Patients Enrolled for Fanconi Anemia
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,619 Total Patients Enrolled
Parinda Mehta, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
188 Total Patients Enrolled
1 Trials studying Fanconi Anemia
70 Patients Enrolled for Fanconi Anemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signs of myelodysplasia or leukemia in your bone marrow.You have taken quercetin or other antioxidants in the last 30 days.You have been diagnosed with Fanconi anemia confirmed by a specific blood test or genetic testing.You have kidney failure and need dialysis.Your bilirubin levels are higher than 3 mg/dl, or your SGPT levels are higher than 200 at the time of enrollment.People of all ages, including grown-ups.
Research Study Groups:
This trial has the following groups:- Group 1: Quercetin - Dietary Supplement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.