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Kinase Inhibitor

Turalio for Leukemia

Phase 1
Recruiting
Led By Rosandra N Kaplan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with NF1 and with malignant peripheral nerve sheath tumor (MPNST) are eligible
Patients must be aged between 3 and 35 years with a body surface area (BSA) of at least 0.55 m^2
Must not have
Ongoing treatment with any other cancer therapy or investigational agent, except for IT chemotherapy for leukemia when indicated
Individuals who require therapy with warfarin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before c1 and then c1d7 and then at each restaging evaluation
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug called PLX3397 to see if it can help treat certain types of cancer. Eligible participants will take the drug once daily for a 28-day cycle, and will have various tests and procedures throughout the study.

Who is the study for?
This trial is for young people aged 3-35 with certain types of cancer that haven't responded to other treatments. They should have solid tumors or specific leukemias (AML, ALL), be able to swallow capsules, and have a performance status indicating they can do daily activities. Patients must not have active infections or be pregnant, and need adequate blood counts and organ function.
What is being tested?
Researchers are testing Turalio(R) (Pexidartinib) in children and young adults with refractory cancers including leukemia and solid tumors like neurofibromas associated with NF1. The goal is to find the highest safe dose of Turalio(R), understand its side effects, and see if it helps treat these cancers.
What are the potential side effects?
While the exact side effects aren't listed here, participants will closely monitor their symptoms in a diary. Side effects could include typical reactions from cancer drugs such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have NF1 and a cancerous tumor in my nerve sheath.
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I am between 3 and 35 years old with a body size of at least 0.55 m^2.
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I can swallow pills.
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I am mostly self-sufficient and can do most activities.
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My condition did not improve after standard treatments.
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I can understand and sign the consent form myself or have someone legally authorized to do so.
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My cancer has come back or didn't respond to treatment, or I couldn't tolerate the treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on any cancer treatment except for specific leukemia therapy.
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I need to take warfarin for my condition.
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I do not have active hepatitis or HIV.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have an infection that hasn't been treated yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first cycle
This trial's timeline: 3 weeks for screening, Varies for treatment, and first cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: determine a phase II dose of TURALIO(R)
Secondary study objectives
Correlative analysis of immune endpoints with response
Safety
To characterize the pharmacokinetic profile
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase IExperimental Treatment1 Intervention
take oral drug daily for a 28 day cycle

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,411 Total Patients Enrolled
Rosandra N Kaplan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
6,226 Total Patients Enrolled

Media Library

PLX3397 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02390752 — Phase 1
Plexiform Neurofibroma Research Study Groups: Phase I
Plexiform Neurofibroma Clinical Trial 2023: PLX3397 Highlights & Side Effects. Trial Name: NCT02390752 — Phase 1
PLX3397 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02390752 — Phase 1
~5 spots leftby Dec 2025
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