Emavusertib, alone or with ibrutinib, for lymphoma in the brain and spinal cord
Official title: 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)
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study tests a pill called emavusertib in people whose lymphoma came back or stopped responding.
Read our full plain-language summary
What the trial team says
This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Key facts
- Registry number
- NCT03328078
- Stage of testing
- Phase 1/Phase 2
- Conditions studied
- Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy, Relapsed Primary Central Nervous System Lymphoma, Refractory Primary Central Nervous System Lymphoma
Where it is running
This trial lists 45 sites.
-
Arizona
- St. Joseph's Hospital and Medical Center (Phoenix)
- Mayo Clinic (Phoenix)
-
California
- City of Hope (Duarte)
- Providence St. John's Health Center (Santa Monica)
- UCLA Department of Medicine - Hematology/Oncology (Santa Monica)
-
Connecticut
- Smilow Cancer Hospital at Yale-New Haven (New Haven)
-
Czechia
- Všeobecná fakultní nemocnice v Praze (Prague)
-
Florida
- Mayo Clinic (Jacksonville)
-
France
- Institut Bergonie (Bordeaux)
- Hopital de la Timone (Marseille)
- Hospital Pitie Salpetriere (Paris)
- Institut Curie Hospital (Paris)
-
Illinois
- Northwestern Memorial Hospital (Chicago)
-
Israel
- Hematology Department Soroka UMC / Heanatology Department (Beersheba)
- Rambam Medical Center (Haifa)
- Hadassah Medical Center / Ein-Carem (Jerusalem)
-
Italy
- Università di Torino Croce e Carle (Cuneo)
- SODc Ematologia Azienda Ospedaliera Universitaria Careggi (Florence)
- IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola)
- IRCCS San Raffaele Scientific Institute (Milan)
-
Massachusetts
- Dana Farber Cancer Institute (Boston)
-
Minnesota
- Mayo Clinic (Rochester)
-
Nebraska
- Fred and Pamela Buffett Cancer Center (Omaha)
-
New Jersey
- Hackensack University Medical Center (Hackensack)
-
New York
- Roswell Park Comprehensive Cancer Center (Buffalo)
- Mt Sinai (New York)
- Columbia University Irving Medical Center (New York)
- Memorial Sloan Kettering Cancer Center (New York)
-
North Carolina
- Duke University Medical Center, Duke Cancer Center (Durham)
-
Ohio
- Cleveland Clinic (Cleveland)
-
Oregon
- Providence Neurological Specialties West (Portland)
-
Pennsylvania
- Hospital of the University of Pennsylvania (Philadelphia)
- UPMC Hilman Cancer Center (Pittsburgh)
-
Poland
- Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz (Gdansk)
- Oddzial Kliniczny Hematologii (Krakow)
- NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy (Warsaw)
-
Spain
- University Hospital Vall d'Hebron (Barcelona)
- MD Anderson Cancer Center Madrid (Madrid)
- Hospital Universitario Virgen del Rocio (Seville)
-
Tennessee
- University of Tennessee Medical Center (Knoxville)
-
Texas
- UT Southwestern Medical Center (Dallas)
- The University of Texas MD Anderson Cancer Center (Houston)
-
Utah
- Huntsman Cancer Institute, University of Utah (Salt Lake City)
-
Washington
- Swedish Cancer Institute (Seattle)
- University of Washington Medical Center (Seattle)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.