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PI3K Inhibitor
Linperlisib for Peripheral T-Cell Lymphoma
Phase 2
Waitlist Available
Led By Ranjit Nair, MD.
Research Sponsored by Shanghai YingLi Pharmaceutical Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study for approximately 2 years
Awards & highlights
Study Summary
This trialwill test a drug to treat a type of cancer in adults in the US. It will measure safety, efficacy & how it's absorbed.
Eligible Conditions
- Peripheral T-Cell Lymphoma (Relapsed/Refractory)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study for approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study for approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response rate (ORR)
Secondary outcome measures
AE
AUCinf
AUClast
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: YY-20394Experimental Treatment1 Intervention
Administer linperlisib (YY-20394) 80 mg (4 tablets) orally with water, once daily, in a 28-day cycle.
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Who is running the clinical trial?
Shanghai YingLi Pharmaceutical Co. Ltd.Lead Sponsor
20 Previous Clinical Trials
1,529 Total Patients Enrolled
Ranjit Nair, MD.Principal InvestigatorMD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You regularly use illegal or recreational drugs, or you have had issues with drug or alcohol abuse within the past year.You have had another type of cancer in the last five years or still have signs of cancer from a previous diagnosis.You have had an allergic reaction to linperlisib or any of its ingredients before.You have a type of lymphoma called angioimmunoblastic T-cell lymphoma (AITL).You are not eligible for a self-donated or donated transplant.You are willing to give a sample of your tumor tissue that was previously collected or undergo a new biopsy before treatment.You have already received treatment for your condition but it did not work.You have multiple conditions that can affect how the drug is taken up and absorbed by your body.You have experienced inflammation of the colon or lungs caused by medication in the past.You had a bleeding episode within the last 2 months, or your doctor thinks you may experience bleeding easily.You have natural-killer/T-cell lymphoma (NKTCL).You have a type of lymphoma called CD30+ PTCL, and have either not responded well to or cannot tolerate the medication brentuximab vedotin.You are 18 years old or older and have agreed to participate in the study.You have a type of lymphoma called peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS).You have a type of lymphoma called anaplastic large cell lymphoma (ALCL), regardless of whether it is ALK positive or ALK negative.You have a specific type of cancer called Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma (MEITL).
Research Study Groups:
This trial has the following groups:- Group 1: YY-20394
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the magnitude of participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this medical research project is actively recruiting individuals since its original posting date of May 1st 2022 and most recent update on October 19th 2022. The study needs 97 participants from one location in total."
Answered by AI
Are there any opportunities for volunteers to join this research project at present?
"According to clinicaltrials.gov, the recruitment process for this trial is still ongoing - it was first posted on May 1st 2022 and revised lastly on October 19th 2022."
Answered by AI
Has the drug YY-20394 attained regulatory approval from the Food and Drug Administration?
"YY-20394's safety rating is 2, as there are reports testifying to its security but a dearth of evidence regarding it efficacy."
Answered by AI
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