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Bruton's Tyrosine Kinase (BTK) Inhibitor
Nivolumab + Ibrutinib for CNS Lymphoma
Phase 2
Waitlist Available
Led By Jason Westin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Relapsed refractory central nervous system lymphoma, pathology confirmed B cell lymphoma either by biopsy or by cerebrospinal fluid (CSF) review. Patient must previously have had one line of systemic therapy for CNS lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying nivolumab and ibrutinib to see if they are effective in treating patients with central nervous system lymphoma.
Who is the study for?
This trial is for adults with relapsed or refractory central nervous system lymphoma. Participants must have adequate organ function, not be pregnant or breastfeeding, agree to use effective contraception, and have had at least one prior systemic therapy. Excluded are those with uncontrolled conditions like hypertension, infections, certain cardiovascular diseases, autoimmune diseases, recent major surgeries or therapies.Check my eligibility
What is being tested?
The study tests the effectiveness of combining two drugs: Nivolumab (an immunotherapy drug) and Ibrutinib (a drug that blocks enzymes needed for cell growth), in treating patients whose central nervous system lymphoma has returned after treatment or hasn't responded to previous treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs; risk of infections; fatigue; liver enzyme elevations; digestive issues; and possibly increased bleeding risk due to Ibrutinib's effect on blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I have B cell lymphoma in my brain or spinal cord that has come back or didn't respond to treatment, and I've had one prior treatment.
Select...
My white blood cell count is healthy without needing medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 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
Incidence of adverse events (AEs)
ORR
Overall survival
+1 moreOther outcome measures
Cytokine profile from microglial cells in cerebrospinal fluid
T cells activation in peripheral blood and cerebrospinal fluid
Tumor characteristics
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment2 Interventions
Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.
Group II: Cohort AExperimental Treatment2 Interventions
Patients receive ibrutinib PO daily on days 1-28. Beginning course 1, patients also receive nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,711 Total Patients Enrolled
8 Trials studying Central Nervous System Lymphoma
428 Patients Enrolled for Central Nervous System Lymphoma
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,584 Total Patients Enrolled
2 Trials studying Central Nervous System Lymphoma
66 Patients Enrolled for Central Nervous System Lymphoma
Jason Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation or disease proven by biopsy that affected my lung function tests significantly.I can take care of myself and perform daily activities.I have not had a stem cell transplant in the last 6 months and do not have graft-versus-host disease.I have not had a stroke or brain bleed in the last 6 months.I need ongoing treatment with a strong medication that affects liver enzymes.I am currently taking warfarin or similar blood thinners.I have B cell lymphoma in my brain or spinal cord that has come back or didn't respond to treatment, and I've had one prior treatment.I have had cancer before, but it's either been treated, in remission for 2+ years, or was a non-melanoma skin cancer or carcinoma in situ.You have a serious medical or mental condition that could make participating in the study risky or affect the accuracy of the results.I have not received any live vaccines in the last 4 weeks.I have an active autoimmune blood disorder needing steroids.I have not had an organ transplant.My white blood cell count is healthy without needing medication.I am not on high-dose steroids or immune suppression medications, or can stop them 3 days before starting the study drugs.I have previously been treated with BTK or PD1 inhibitors.I haven't had major surgery, radiation, or cancer therapy in the last 4 weeks.I do not have autoimmune diseases like Crohn's, ulcerative colitis, rheumatoid arthritis, lupus, or Wegener's.I don't have any severe illnesses that could affect my safety or interfere with the study medication.I do not have serious heart problems like recent heart attacks or uncontrolled heart disease.I do not have active hepatitis B or C, and I am not HIV positive.I am taking high dose steroids or medications that suppress my immune system.I cannot take medicine by mouth due to a digestive condition.I do not have any ongoing serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is ibrutinib an accepted medical treatment by the FDA?
"While there is some data supporting the safety of Ibrutinib, it is still classified as a Phase 2 medication. This means that, currently, there is no evidence to support its efficacy."
Answered by AI
What are some of the conditions that ibrutinib has been known to help?
"Ibrutinib is a medication that can effectively treat various cancers, including melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Could you please list any other times Ibrutinib has been studied in a clinical setting?
"There are 900 ongoing trials for Ibrutinib, with 105 of them being in the critical third phase. The majority of these studies originate from Basel, BE; however, there are 47502 locations running clinical trials for this medication globally."
Answered by AI
Have these methods been used before in other clinical trials?
"Ibrutinib is being trialed in 900 separate active studies across 53 countries and 2580 cities. The first Ibrutinib trial began in 2010, was sponsored by Medarex, involved 127 participants, and completed Phase 1 drug approval. Since then, 343 similar trials have been completed."
Answered by AI
Are there any more slots open for this clinical trial?
"That is correct. The clinical trial's profile on the website ClinicalTrials.gov shows that the study is actively recruiting patients. 40 participants are being recruited from a single location for the trial, which was originally posted on February 15th, 2019 and last edited on March 26th, 2021."
Answered by AI
How many people are being given the chance to participate in this trial?
"Yes, this trial is still open to new participants according to the listings on clinicaltrials.gov. The study was first posted February 15th, 2019 and received its most recent update March 26th, 2021. At present, 1 site is admitting 40 patients into the trial."
Answered by AI
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