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Leniolisib for Activated PI3K Delta Syndrome
Study Summary
This trial will study the safety and effectiveness of a new drug called leniolisib in kids with a rare condition called activated phosphoinositide 3-kinase delta syndrome.
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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- Your heart rate is within a normal range.I haven't taken B cell depleters like rituximab in the last 6 months.I do not have serious heart rhythm problems.I am 10 years or older and my heart rate is between 50 to 100 bpm.I weigh between 13 kg and 45 kg.I will use effective birth control for 30 days after my last study procedure.My family has a history of long QT syndrome or Torsades de Pointes.I am 10 years or older with a heart rate between 50 to 100 bpm.I, or my child, will follow study rules about menstruation if it starts after screening.I am not taking any medications that affect my heart's rhythm, or I can stop them for the study.I am not allergic to lactose monohydrate.I am not allergic to Opadry yellow.I will not engage in heterosexual activity for the study duration and 6 months after.My heart rate is between 60 and 140 beats per minute.My condition involves a PI3Kδ genetic mutation.I have given my written consent for the study, as approved by an ethics committee.This criterion seems to be incomplete or out of context for determining clinical trial eligibility based on a patient's condition or treatment history. Magnesium stearate is commonly mentioned as a component in medications or supplements, not as a criterion for clinical trial eligibility.I have a measurable cancerous node identified by MRI or CT scan in the last 6 months.I am not allergic to sodium starch glycolate (Type A).I am not allergic to colloidal silicon dioxide.I am not allergic to microcrystalline cellulose.I am a woman not able to have children or a man willing to use contraception.I am allergic to or cannot take hypromellose.I have used or am using medication that weakens my immune system.I haven't taken mTOR or PI3Kδ inhibitors in the last 6 weeks.I can take pills without any trouble.I am not on long-lasting immunosuppressive drugs.
- Group 1: Leniolisib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Could you please elaborate on the age requirements for participants in this trial?
"This clinical trial is looking for pediatric patients aged 4-11 years old."
Could I qualify to be a test subject for this experiment?
"This study is looking for 15 participants who have APDS and are between the ages of 4 and 11. The most important criteria that candidates must meet are as follows: Patient weighs ≥13 kg and <45 kg at baseline., Patient is male or female and between the age of 4 to 11 years old at time of the first study procedure. Females should be of nonchildbearing potential at screening., Patient has at least 1 measurable nodal lesion on magnetic resonance imaging (MRI)/low-dose computed tomography (CT)., Patient has nodal or extranodal lymphoproliferation and clinical findings consistent with APDS"
What have been the findings of studies on Leniolisib's safety profile?
"Leniolisib's safety is well documented, as this drug has progressed to Phase 3 clinical trials. In our estimation, Leniolisib carries a risk level of 3."
Can new patients still enroll in this clinical trial?
"According to the website clinicaltrials.gov, this study is no longer recruiting patients for participation. The trial was originally posted on 8/31/2022 but was most recently edited on 7/8/2022. 1 other trials are enrolling participants currently."
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