Actively Recruiting
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Led by Stanford University · Updated on 2026-01-12
16
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
CONDITIONS
Official Title
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior confirmed diagnosis of AML based on WHO criteria
- Disease relapse or refractory AML after at least 2 cycles of intensive chemotherapy or 4 cycles of non-intensive chemotherapy or hypomethylating agents
- No prior treatment with niclosamide
- Age 2 to 30 years
- Body surface area (BSA) less than or equal to 2.10 m2
- Able to tolerate oral or nasogastric medications
- Performance status: Lansky score 50 or higher (if age 16 or younger), Karnofsky score 50% or higher (if older than 16 years)
- Life expectancy greater than 4 weeks
- Platelet count of at least 10,000/mm3 (platelet transfusion allowed if below this)
- Creatinine clearance at least 60 mL/min/1.73 m2 within 14 days before treatment
- Total bilirubin less than or equal to 2.0 times institutional upper limit of normal (ULN) within 14 days before treatment (except Gilbert's syndrome up to 3.0 x ULN)
- AST and ALT less than or equal to 3.0 times ULN within 14 days before treatment
- Last dose of anti-cancer therapy at least 2 weeks or 3 half-lives before study treatment, whichever is longer
- For prior stem cell transplant recipients, no graft-versus-host disease and more than 60 days since transplant
- Females of reproductive potential must have a negative pregnancy test within 14 days before treatment and agree to use contraception during and 30 days after treatment
- Men must agree to use contraception during and 30 days after treatment
- Ability to understand study purpose and risks and provide informed consent
You will not qualify if you...
- Received any anticancer therapy within 2 weeks before starting study treatment (hydroxyurea allowed to control high white blood cell count but must stop 24 hours before treatment)
- Receiving other investigational agents including niclosamide
- Unresolved toxicities from prior cancer therapy above Grade 1 except alopecia
- Diagnosis of acute promyelocytic leukemia (M3-AML)
- Active central nervous system leukemia unless cleared with intrathecal chemotherapy
- Known congenital bleeding disorders
- Active uncontrolled systemic infection
- Significant gastrointestinal disorders affecting absorption or with bowel obstruction
- Unable to take niclosamide in available forms
- Uncontrolled illness or psychiatric/social conditions limiting study compliance
- Pregnant or breastfeeding females
- Known active hepatitis C
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
N
Nancy Sweeters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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