Ibrutinib for Lymphoma, B-Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lymphoma, B-Cell+4 More
Ibrutinib - Drug
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

1 of 3

Other trials for Lymphoma, B-Cell

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

2 of 3
This is further along than 68% of similar trials

Other trials for Lymphoma, B-Cell

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 preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

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.