Ibrutinib for Lymphoma, B-Cell
Phase-Based Progress Estimates
Effectiveness
Safety
Lymphoma, B-Cell+4 More
Ibrutinib - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is studying nivolumab and ibrutinib to see if they are effective in treating patients with central nervous system lymphoma.
Eligible Conditions
- Lymphoma, B-Cell
- Lymphoma
- Central Nervous System B-Cell Non-Hodgkin Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 2 years
Week 4
ORR
Year 2
Cytokine profile from microglial cells in cerebrospinal fluid
T cells activation in peripheral blood and cerebrospinal fluid
Tumor characteristics
Day 30
Incidence of adverse events (AEs)
Year 1
Overall survival
Year 1
Progression free survival (PFS)
Up to 2 years
Overall response rate (ORR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Cohort A
1 of 2
Cohort B
1 of 2
Experimental Treatment
40 Total Participants · 2 Treatment Groups
Primary Treatment: Ibrutinib · No Placebo Group · Phase 2
Cohort AExperimental Group · 2 Interventions: Ibrutinib, Nivolumab · Intervention Types: Drug, Biological
Cohort BExperimental Group · 2 Interventions: Ibrutinib, Nivolumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,848 Total Patients Enrolled
249 Trials studying Lymphoma, B-Cell
19,248 Patients Enrolled for Lymphoma, B-Cell
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,723 Total Patients Enrolled
35 Trials studying Lymphoma, B-Cell
2,083 Patients Enrolled for Lymphoma, B-Cell
Jason WestinPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
155 Total Patients Enrolled
3 Trials studying Lymphoma, B-Cell
155 Patients Enrolled for Lymphoma, B-Cell
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have relapsed refractory CNS lymphoma, pathology confirmed B cell lymphoma either by biopsy or by cerebrospinal fluid (CSF) review
For Gilbert's disease, total bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin.
You have serum creatinine level of < 1.5 x ULN.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Cancer Related
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