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Antimetabolite
Zanubrutinib + Pemetrexed for CNS Lymphoma
Phase 2
Recruiting
Led By Yuliya Linhares, M.D.
Research Sponsored by Yuliya Linhares
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 2 years and 5 years
Awards & highlights
Study Summary
This trial evaluates a treatment for relapsed/refractory primary central nervous system lymphoma and isolated central nervous system relapse of B cell lymphoma. It assesses how well people respond, side effects, and safety.
Who is the study for?
This trial is for people with relapsed or refractory primary or secondary central nervous system lymphoma. Participants must have certain types of B cell lymphoma, measurable disease, and adequate organ function. They should not be pregnant, use effective contraception, and have a life expectancy of at least 2 months. Excluded are those with recent other treatments, significant heart issues, active infections requiring treatment within the last week, or known bleeding disorders.Check my eligibility
What is being tested?
The study tests pemetrexed combined with zanubrutinib (induction therapy), followed by maintenance therapy with zanubrutinib alone in patients whose CNS lymphoma has returned after treatment or didn't respond well to previous therapies. It aims to assess how well patients respond to this regimen and monitor their survival rates as well as any side effects.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drugs causing inflammation in various organs; blood-related issues such as anemia; liver enzyme elevations indicating potential liver damage; fatigue; digestive problems like nausea and vomiting; risk of infection due to lowered immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response Rate (ORR) to Induction Therapy
Secondary outcome measures
Best Overall Response Rate (ORR) after transplant, WBRT + zanubrutinib maintenance, or zanubrutinib maintenance alone
Change in Overall Survival (OS)
Change in Progression-Free Survival (PFS)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Induction Therapy + SOC TreatmentExperimental Treatment4 Interventions
Participants will receive the induction therapy (oral zanubrutinib + IV pemetrexed) and be placed into one of the cohorts according to standard of care (SOC) treatment:
Cohort 1: Induction Therapy + Autologous Stem Cell Transplant (ASCT) After completion of the induction therapy, ASCT candidates will undergo transplant as per SOC. If the transplant is delayed and 8 induction cycles have been completed, oral zanubrutinib maintenance will proceed until transplant, but will not occur after transplant.
Cohort 2: Induction Therapy + Whole Brain Radiation Therapy (WBRT) After completion of the induction therapy, WBRT candidates will undergo WBRT as per SOC. Oral zanubrutinib maintenance will start 7-10 days after the completion of WBRT. 28-d maintenance cycles will continue until disease progression.
Cohort 3: Induction Therapy Alone After completion of the induction therapy, 28-day oral zanubrutinib maintenance cycles will begin and continue until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Stem Cell Transplant (ASCT)
2012
Completed Phase 2
~190
Whole Brain Radiation Therapy (WBRT)
2004
Completed Phase 3
~370
Zanubrutinib
2017
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Yuliya LinharesLead Sponsor
Baptist Health South FloridaLead Sponsor
50 Previous Clinical Trials
7,864 Total Patients Enrolled
BeiGeneIndustry Sponsor
178 Previous Clinical Trials
29,077 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed diagnosis of CNS lymphoma or secondary CNS involvement by diffuse large B cell lymphoma.I am mostly independent in my daily activities.I have B cell non-Hodgkin's lymphoma that can be measured.I do not have any serious illnesses that are not under control.I do not have any other active cancer except for allowed exceptions.I understand and can follow the study's requirements.I have not received any live vaccines recently.I have allergies or reactions to certain medications.I have been treated for lymphoma with specific medications.My cancer got worse during the first treatment or came back after it initially worked.My scans show no signs of lymphoma throughout my body.My blood tests show my organs and bone marrow are working well.I have eye lymphoma with a confirmed diagnosis and a measurable brain tumor.I have a bleeding disorder or had a recent clotting event.I am using effective birth control and will continue for 90 days after my last dose.I have an infectious disease that meets certain criteria.I am not on any immune or targeted therapy not listed in this study.I have a serious heart condition that is currently causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Induction Therapy + SOC Treatment
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.
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