Emavusertib for Relapsed or Refractory Primary Central Nervous System Lymphoma
This study is testing a drug called emavusertib, alone or with ibrutinib, for adults with primary central nervous system lymphoma (PCNSL) that has come back (relapsed) or hasn't responded to previous treatments (refractory). Emavusertib is a kinase inhibitor, which means it blocks certain proteins that can help cancer cells grow. The main goals are to find a safe dose of emavusertib and see how well it is tolerated over 12 months. You may be eligible if you are at least 18 years old, have a life expectancy of at least 3 months, and have a confirmed diagnosis of PCNSL. The study is open-label, meaning you and your doctors will know which treatment you are receiving.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 152 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and tolerability are measured at 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
At a glance
Conditions
NCT03328078
Where you'd take part
This study runs at 45 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope
Duarte, Californiano site contact published
Recruiting
Cleveland Clinic
Cleveland, Ohiono site contact published
Recruiting
Dana Farber Cancer Institute
Boston, Massachusettsno site contact published
Recruiting
Duke University Medical Center, Duke Cancer Center
Durham, North Carolinano site contact published
Recruiting
Fred and Pamela Buffett Cancer Center
Omaha, Nebraskano site contact published
Recruiting
Hadassah Medical Center / Ein-Carem
Jerusalem, Israelno site contact published
Recruiting
Hematology Department Soroka UMC / Heanatology Department
Beersheba, Israelno site contact published
Recruiting
Hopital de la Timone
Marseille, Franceno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part A: To determine the safety and tolerability of emavusertib as a monotherapy and in combination with ibrutinib: dose-limiting toxicity (DLT)12 months
The number of participants with a dose-limiting toxicity (DLT) in the first treatment cycle
- Part A: Maximum tolerated dose (MTD) of emavusertib as a monotherapy and in combination with ibrutinib measured by dose-limiting toxicities (DLTs)12 months
MTD determined by the highest dose level studied at which fewer than 2 out of 6 subjects (\<33%) experience a dose limiting toxicity.
- Part A: Recommended Phase 2 Dose (RP2D) of emavusertib as a monotherapy and in combination with ibrutinib based on overall tolerability data12 months
RP2D selected based on overall tolerability data from all participants treated at different dose levels and will not exceed the MTD.
- Part B: Overall Response Rate (ORR) in participants with R/R PCNSL18 months
- Part C: ORR in participants with R/R PCNSL18 months