← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before c1 and then c1d7 and then at each restaging evaluation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have NF1 and a cancerous tumor in my nerve sheath.

Select...

I am between 3 and 35 years old with a body size of at least 0.55 m^2.

Select...

I can swallow pills.

Select...

I am mostly self-sufficient and can do most activities.

Select...

My condition did not improve after standard treatments.

Select...

I can understand and sign the consent form myself or have someone legally authorized to do so.

Select...

My cancer has come back or didn't respond to treatment, or I couldn't tolerate the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first cycle

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: determine a phase II dose of TURALIO(R)

Secondary outcome measures

Correlative analysis of immune endpoints with response

Safety

To characterize the pharmacokinetic profile

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase IExperimental Treatment1 Intervention

take oral drug daily for a 28 day cycle

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,587 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in the study for new participants?

"Affirmative. The information on clinicaltrials.gov shows that this trial is currently enrolling participants. It was first posted in April, 2015 and updated most recently in November, 2022 with the requirement for 54 patients from two sites to be recruited"

Answered by AI

What is the aggregate amount of individuals contributing to this clinical experiment?

"Affirmative. Findings from clinicaltrials.gov demonstrate that this research is still seeking participants, having initially been posted on April 29th 2015 and most recently updated November 17th 2022. 54 individuals must be recruited to the two sites involved in the study."

Answered by AI

In what ways has Turalio been used to aid in treatments?

"Turalio has the potential to alleviate morbidity, fibrous histiocytoma of tendon sheath, and any functional limitations."

Answered by AI

What aims is this experimentation attempting to achieve?

"This investigation has a primary objective to assess the appropriate dosing of PLX3397 in its first cycle. Secondary objectives include characterizing pharmacokinetics, gauging Turalio's tolerability and biologic activity, as well as correlating immune endpoints with response rates in pediatric cancer patients (AML/ALL) suffering from recurrent or refractory solid tumors."

Answered by AI

What are the safety profiles associated with Turalio ingestion?

"Based on the limited clinical data available, Turalio's safety was rated an 1 on our team at Power's scale. This signifies that Phase 1 of this trial is still underway and no definitive conclusions have been drawn about efficacy or safety."

Answered by AI

What requirements must be met for individuals to become eligible for the research project?

"To become a part of this medical trial, patients must have sarcoma and be between 3-35 years old. The research team is looking to recruit 54 people in total."

Answered by AI

Is the age requirement for this clinical trial flexible enough to accommodate individuals over 65?

"This clinical trial only allows for enrolment of individuals aged 3 to 35. Conversely, 650 and 1560 trials are available for those below 18 and above 65 respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...

2015. "Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02390752.

All > Acute Lymphocytic Leukemia > Neurofibromatosis