Niclosamide in Pediatric Patients With Relapsed and Refractory AML

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05188170
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Niclosamide — DRUG
    Niclosamide will be administered orally for 14 days. Each dose will be followed by backbone chemotherapy

Study Details

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.

Key Dates

Start date
Nov 21, 2022
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Niclosamide 250 mg/m2 /day divided BID
  • Experimental: Niclosamide 500 mg/m2 /day divided BID
  • Experimental: Niclosamide 800 mg/m2 /day divided BID
  • Experimental: Niclosamide 1200 mg/m2 /day divided BID

Primary Outcome Measure

Dose-limiting toxicity [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Nancy Sweeters, RN, PNP
[email protected]
650-721-4074
Kathleen Sakamoto, M.D., Ph.D (PRINCIPAL_INVESTIGATOR)
Adam Frymoyer, MD (SUB_INVESTIGATOR)
Norman Lacayo, MD (SUB_INVESTIGATOR)
Namrata Patel, PharmD (SUB_INVESTIGATOR)
Jennifer Kamens, M.D (SUB_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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