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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 up to 5 years
Awards & highlights
Study Summary
This trial tests a drug for relapsed or refractory mantle cell lymphoma to assess safety, tolerability, and efficacy.
Who is the study for?
This trial is for people with a confirmed diagnosis of mantle cell lymphoma (MCL) who have relapsed or are not responding to treatment. They must have measurable disease, previous treatments including CD20-based therapy and BTK inhibitors, and be in fairly good health based on ECOG status. People can't join if they've had certain recent transplants, active severe infections, cardiovascular issues, prior Bcl-2 inhibitor use like venetoclax, or other cancers within the last 3 years.Check my eligibility
What is being tested?
The study tests BGB-11417 as a single agent for MCL that's come back or isn't getting better after treatment. It has two parts: first finding the safest dose and then checking how well it works at that dose against MCL.See study design
What are the potential side effects?
While specific side effects of BGB-11417 aren't listed here, similar drugs often cause nausea, diarrhea, fatigue, low blood counts increasing infection risk; liver function changes; and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Therapeutic procedure
Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
+1 moreSecondary outcome measures
Duration of Response (DOR) as assessed by investigator and IRC
Overall Response Rate (ORR) as assessed by investigator
Overall Survival (OS)
+15 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Participants will receive sonrotoclax
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Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,692 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.I have a serious heart condition.My diagnosis of mantle cell lymphoma is confirmed by tissue analysis.My condition has returned or didn't respond to treatment.I have had treatments for MCL including anti-CD20 therapy and a BTK inhibitor.I can provide tissue samples for my mantle cell lymphoma diagnosis.I am currently being treated for a serious infection.My lymphoma has spread to my brain or spinal cord.I have not had major surgery or a significant injury in the last 4 weeks.My cancer can be measured by tests.I can care for myself and am up and about more than 50% of my waking hours.I haven't had cancer in the last 3 years, except for certain non-aggressive types or skin cancer.I had a stem cell transplant or CAR T-cell therapy recently, or I'm currently on immunosuppressants for graft-vs-host disease.I have been treated with a BCL-2 inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
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.
How many participants has this experiment attracted thus far?
"Confirmed. The clinical trial is open for enrollment and the details posted on clinicaltrials.gov were last edited on January 23rd 2023. Currently, 98 participants are needed from a single site."
Answered by AI
What potential perils do patients face when participating in a Single Arm program?
"According to our evaluation, the safety rating of Single Arm is set at a 2 due its Phase 2 status. This implies that while there are some indications of safety, efficacy has yet to be established."
Answered by AI
Is this investigation still enrolling participants?
"According to clinicaltrials.gov, this trial is recruiting patients at the present time. The study was first uploaded on September 5th 2022 and recently updated on January 23rd 2023."
Answered by AI
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