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New treatment option for Acute Myeloid Leukemia (AML)
Official title Niclosamide in Pediatric Patients With Relapsed and Refractory AML
ClinicalTrials.gov ID: NCT05188170
What this study is testing
What is Niclosamide?
Niclosamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25
You may be able to join if
- 1\. Prior morphologically-confirmed diagnosis of AML based on WHO Criteria 2. Has previously failed all available and suitable therapies for AML...
- 5% blasts in the peripheral blood (confirmed by flow cytometry, cytogenetics or FISH), ≥ 1% MRD \+ by flow cytometry, FISH, PCR or NGS, and not...
- 60 mL/min/1.73 m2 (by the Cockcroft-Gault method) within 14 days prior to treatment initiation 10. Total bilirubin ≤ 2.0 x institutional upper limit...
- 3.0 x ULN) 11. SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT)
- 3.0 x ULN within 14 days prior to treatment initiation 12. Patients must have received their last dose of anti-cancer therapy (chemotherapy...
You likely can't join if
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment...
- Receiving any other investigational agents, including niclosamide.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise...
- Acute promyelocytic leukemia (French-American-British Class M3-AML)
- Known active central nervous system (CNS) leukemia; people can enroll on study if CNS disease can be cleared with intrathecal chemotherapy, in the...
- Known congenital bleeding disorders, including but not limited to hemophilia
See the full eligibility criteria
- 1\. Prior morphologically-confirmed diagnosis of AML based on WHO Criteria 2. Has previously failed all available and suitable therapies for AML. Disease relapse or the presence of refractory disease after ≥ 2 cycles of...
- 5% blasts in the peripheral blood (confirmed by flow cytometry, cytogenetics or FISH), ≥ 1% MRD \+ by flow cytometry, FISH, PCR or NGS, and not attributable to another cause (EXCEPTION: people with frank disease...
- 60 mL/min/1.73 m2 (by the Cockcroft-Gault method) within 14 days prior to treatment initiation 10. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) within 14 days prior to treatment initiation...
- 3.0 x ULN) 11. SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT)
- 3.0 x ULN within 14 days prior to treatment initiation 12. Patients must have received their last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted agents, radiotherapy or investigational therapy) at...
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg...
- Receiving any other investigational agents, including niclosamide.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the inclusion/exclusion criteria with the exception of...
- Acute promyelocytic leukemia (French-American-British Class M3-AML)
- Known active central nervous system (CNS) leukemia; people can enroll on study if CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the treating physician
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel disease or ulcerative colitis, or partial or...
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Lactating or pregnant female
- Known active hepatitis C
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.