Spots Global Cancer Trial Database for A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
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Trial Identification
Brief Title: A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
Official Title: An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
Study ID: NCT03328078
Study Description
Brief Summary: This is a multi-center, open-label trial to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib (CA-4948) in adult patients with relapsed or refractory (R/R) hematologic malignancies. Part A will evaluate the safety and tolerability of escalating doses of emavusertib as monotherapy (Part A1), and in combination with ibrutinib. In Protocol Version (v) 1.0 through v6.0, patients with Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma (WM/LPL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) were also enrolled at ibrutinib doses of 420 mg (Part A2). Enrollment into Parts A1 and A2 has been closed. Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in patients with primary central nervous system lymphoma (PCNSL).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
UCLA Department of Medicine - Hematology/Oncology, Santa Monica, California, United States
Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States
Mayo Clinic, Jacksonville, Florida, United States
Mayo Clinic, Rochester, Minnesota, United States
Fred and Pamela Buffett Cancer Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Všeobecná fakultní nemocnice v Praze, Prague, , Czechia
Institut Curie Hospital, Paris, , France
Hematology Department Soroka UMC / Heanatology Department, Be'er Sheva, , Israel
Hadassah Medical Center / Ein-Carem, Jerusalem, , Israel
Università di Torino Croce e Carle, Cuneo, , Italy
SODc Ematologia Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
IRCCS San Raffaele Scientific Institute, Milano, , Italy
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz, Gdańsk, , Poland
Oddzial Kliniczny Hematologii, Kraków, , Poland
NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy, Warsaw, , Poland
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Contact Details
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