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Turalio for Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have NF1 and a cancerous tumor in my nerve sheath.I am between 3 and 35 years old with a body size of at least 0.55 m^2.I can swallow pills.I am mostly self-sufficient and can do most activities.I am not on any cancer treatment except for specific leukemia therapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer has come back or didn't respond to treatment, or I couldn't tolerate the treatment.I am on steroids and meet the specific requirements for their use.I have stopped all previous cancer treatments by the required time before joining.My blood, liver, and kidney functions are all within normal ranges.I do not have active hepatitis or HIV.I can understand and sign the consent form myself or have someone legally authorized to do so.I need to take warfarin for my condition.My condition did not improve after standard treatments.I haven't taken drugs that strongly affect CYP3A4 enzyme recently.I have recovered from side effects of previous cancer treatments.I have an infection that hasn't been treated yet.
- Group 1: Phase I
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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."
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."
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."
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