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Niclosamide in Pediatric Patients With Relapsed and Refractory AML

NCT05188170 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-12

No results posted yet for this study

Summary

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

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Niclosamide

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

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Pediatric Cancer Research Foundation (PCRF)

    collaborator UNKNOWN

  • CURE Childhood Cancer, Inc.

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Kathleen M Sakamoto, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188170 on ClinicalTrials.gov