← Back to Search

PI3K Inhibitor

Ibrutinib for Lymphoma

Phase 1
Waitlist Available
Led By Connie Batlevi, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 1 year
Awards & highlights

Study Summary

This trial is testing if combining buparlisib and ibrutinib leads to better treatment results for patients with relapsed or refractory FL, MCL, or DLBCL.

Eligible Conditions
  • Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Buparlisib and IbrutinibExperimental Treatment2 Interventions
This is a two stage protocol comprised of a single institution phase Ib dose escalation trial. The first stage is a standard 3+3 phase I dose escalation trial to assess the safety of buparlisib and ibrutinib. The second stage is a single center expansion cohort in MCL, FL and DLBCL respectively evaluating the efficacy of buparlisib and ibrutinib combination. Treatment will be with ibrutinib orally daily and buparlisib orally daily. A cycle is defined as 4 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death with a maximum duration for 36 cycles, not exceeding 36 months on therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Buparlisib
2014
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor
2,857 Previous Clinical Trials
4,197,770 Total Patients Enrolled
58 Trials studying Lymphoma
167,959 Patients Enrolled for Lymphoma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,481 Total Patients Enrolled
5 Trials studying Lymphoma
78 Patients Enrolled for Lymphoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,889 Total Patients Enrolled
155 Trials studying Lymphoma
8,702 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Cancer ResearchJournal
Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring
Stewart, Caitlin M., Laure Michaud, Karissa Whiting, Reiko Nakajima, Chelsea Nichols, Stephanie De Frank, Paul A. Hamlin Jr, et al.. 2022. “Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2183.
Clinical Cancer ResearchJournal
Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring
Stewart, Caitlin M., Laure Michaud, Karissa Whiting, Reiko Nakajima, Chelsea Nichols, Stephanie De Frank, Paul A. Hamlin Jr, et al.. 2022. “Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2183.
Clinical Cancer ResearchJournal
Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring
Stewart, Caitlin M., Laure Michaud, Karissa Whiting, Reiko Nakajima, Chelsea Nichols, Stephanie De Frank, Paul A. Hamlin Jr, et al.. 2022. “Phase I/ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-free DNA Monitoring”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2183.
clinicaltrials.govStudy
A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma
2016. "A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02756247.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top