Fosciclopirox + Cytarabine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: CicloMed LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new drug, fosciclopirox, alone and with cytarabine, in patients with a type of blood cancer that hasn't responded to other treatments. The goal is to see if these drugs can stop cancer growth or kill the cancer cells.

Eligibility Criteria

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.

Inclusion 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.

Patient provided signed and dated informed consent prior to initiation of any study procedures

+10 more

Exclusion Criteria

Patients has any serious and/or uncontrolled concurrent medical conditions (e.g., uncontrolled infection, uncontrolled diabetes) or psychiatric illness that could, in the investigator's opinion, cause unacceptable safety risks or potentially interfere with the completion of the treatment according to the protocol

Patient has known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion

I have been diagnosed with acute promyelocytic leukemia or Ph+ AML.

+10 more

Participant Groups

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.

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).