Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from informed consent form through follow up visit (30±5 days after last dose of study drug)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from informed consent form through follow up visit (30±5 days after last dose of study drug)
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 • NCT0301267245%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the required range.My white blood cell count is ≤ 25.0 x 10^9/L and I haven't taken hydroxyurea for 72 hours before my test.I have been diagnosed with acute promyelocytic leukemia or Ph+ AML.My liver is functioning well enough for the trial, based on my blood test results.I am currently on iron replacement therapy.I have tried all standard treatments without success.I have not received a live vaccine in the last 4 weeks.I am currently pregnant or breastfeeding.You have an allergy or sensitivity to any ingredient in fosciclopirox.I have taken Hydrea within the last 3 days.I am 18 years old or older.I have chronic liver disease or hepatitis B or C.My heart is strong enough for the trial, with an EF ≥45% and a safe QTcF.My AML has returned after treatment or hasn't responded to at least 2 treatment cycles.I can take care of myself and am up and about more than half of my waking hours.I had a stem cell transplant over 100 days ago and do not have graft versus host disease.I have another active cancer.I have a serious heart condition.I am currently taking warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 - Fosciclopirox + Cytarabine
- Group 2: Cohort 1 - Fosciclopirox only
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.
Share this study with friends
Copy Link
Messenger