← Back to Search

Other

Fosciclopirox + Cytarabine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by CicloMed LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has relapsed AML after complete remission of any duration as evidenced by presence of neoplastic blasts in the bone marrow confirmed by flow cytometry OR has refractory AML, defined as primary refractory to at least 2 cycles of induction therapy
No other therapy exists or patient has received all standard therapies that would be potentially curative or might provide significant benefit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from informed consent form through follow up visit (30±5 days after last dose of study drug)
Awards & highlights

Study Summary

This trial will study the effects of fosciclopirox given alone and with cytarabine in patients with relapsed or refractory acute myeloid leukemia. The trial will enroll up to 14 evaluable patients in each of two cohorts. If at least 4 of 14 patients respond to fosciclopirox given alone in the first cohort, 14 additional patients will be enrolled in the second cohort. If at least 4 of 14 patients respond to fosciclopirox given with cytarabine in the second cohort, the trial will continue. Otherwise, the trial will be stopped for futility.

Who is the study for?
Adults (≥18 years) with relapsed/refractory Acute Myeloid Leukemia who've exhausted standard treatments, have a life expectancy of ≥3 months, and meet specific health criteria including adequate organ function. They must not be pregnant/breastfeeding, have certain other diseases or infections, or be on conflicting medications.Check my eligibility
What is being tested?
The trial is testing Fosciclopirox alone and in combination with Cytarabine to evaluate its effectiveness and safety for treating AML. The study will progress through different cohorts based on the observed disease response rate to determine if further investigation is warranted.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to liver or kidney function due to the drug's properties and interactions with other medications. Close monitoring for general drug-related side effects such as nausea, fatigue, blood count changes etc., would also be expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My AML has returned after treatment or hasn't responded to at least 2 treatment cycles.
Select...
I have tried all standard treatments without success.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My kidney function is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from informed consent form through follow up visit (30±5 days after last dose of study drug)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from informed consent form through follow up visit (30±5 days after last dose of study drug) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Myeloid Leukemia (AML) response
Frequency and type of treatment-related AEs

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03012672
45%
Febrile Neutropenia
25%
Bacteremia
20%
Rash Maculo-Papular
20%
Hypoxia
15%
Tumor Lysis Syndrome
15%
Hyperglycemia
15%
Cardiac Troponin I Increased
10%
Pulmonary Edema
10%
Urinary Tract Infection
10%
Intracranial Hemorrhage
10%
Headache
10%
Edema Limbs, Volume Overload
10%
Delirium
10%
Soft Tissue Infection
10%
COPD Exacerbation
10%
Atrial Fibrillation
10%
Blood Bilirubin Increased
10%
Respiratory Failure
5%
Generalized Edema
5%
Vascular Access Complication
5%
Colonic Pseudo-Obstruction
5%
Acute Kidney Injury
5%
Nausea
5%
Multi-organ failure
5%
Sepsis
5%
Right Ventricular Dysfunction
5%
Alkalosis
5%
Anorexia
5%
Dyspnea
5%
Bronchopulmonary Hemorrhage
5%
Hypotension
5%
Lung Infection
5%
Optic Nerve Disorder
5%
Hypertension
5%
Hypokalemia
5%
Hyponatremia
5%
Paroxysmal Atrial Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ARM I (HIGHER-DOSE):
ARM II (LOWER-DOSE):

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 - Fosciclopirox + CytarabineExperimental Treatment1 Intervention
To be implemented if a disease response is not seen in Cohort 1a. Cohort 2a will have an initial 14 study participants treated with fosciclopirox and cytarabine. If a disease response is seen, an additional 14 study participants will be enrolled (Cohort 2b).
Group II: Cohort 1 - Fosciclopirox onlyExperimental Treatment1 Intervention
An initial 14 study participants will be enrolled in Cohort 1a and will be treated with fosciclopirox. If there is a disease response, an additional 14 study participants will be enrolled into Cohort 1 (Cohort 1b).

Find a Location

Who is running the clinical trial?

CicloMed LLCLead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Fosciclopirox (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04956042 — Phase 1 & 2
Acute Myelogenous Leukemia Research Study Groups: Cohort 2 - Fosciclopirox + Cytarabine, Cohort 1 - Fosciclopirox only
Acute Myelogenous Leukemia Clinical Trial 2023: Fosciclopirox Highlights & Side Effects. Trial Name: NCT04956042 — Phase 1 & 2
Fosciclopirox (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956042 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will this research endeavor involve?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial has been actively searching for participants since August 27th 2021 and the most recent edit occurred May 28th 2022. The study requires a total of 28 patients from 2 sites to complete its research objectives."

Answered by AI

What past research has explored the effects of Fosciclopirox?

"Currently, 234 clinical trials are being conducted related to fosciclopirox. Of those studies, 60 have advanced to Phase 3 of the trial process. Although New york has the most research centers for this medication, 9778 locations across the world are running these experiments."

Answered by AI

What medical purposes is Fosciclopirox typically applied to?

"Fosciclopirox is an effective way to address leptomeningeal metastases, acute promyelocytic leukemia, and meningeal leukemia."

Answered by AI

Are there vacancies in this medical trial that participants can fill?

"Confirmed, the trial is actively recruiting. According to clinicaltrials.gov, this medical research was posted on August 27th 2021 and underwent its most recent update on May 28th 2022. A total of 28 patients are needed from 2 different sites for participation in this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia
2021. "Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956042.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top