A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive tacabrutideg or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive tacabrutideg versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).
Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either tacabrutideg or the investigator's choice of treatment.
"Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."
Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
clinicaltrials@beonemed.com1.877.828.5568
Los Angeles, California 90095-3075, United States
Grand Rapids, Michigan 49503-2560, United States
Omaha, Nebraska 68130-2042, United States
Eugene, Oregon 97401, United States
Caba, 1425, Argentina
Caba, C1431, Argentina
Caba, CP1114, Argentina
Ciudad Autonoma Buenos Aires, 1413, Argentina
Ciudad Autonoma Buenos Aires, 1426, Argentina
Bedford PK, South Australia SA 5042, Australia
Florianópolis, 88020-210, Brazil
São Paulo, 05652-900, Brazil
Greenfield Park, Quebec J4V 2H1, Canada
SaintJerome, Quebec J7Z 5T3, Canada
Freiburg im Breisgau, 79106, Germany
Hiroshima, Hiroshima 730-8619, Japan
AmagasakiCity, Hyōgo 660-8550, Japan
KyotoShi, Kyoto 602-8566, Japan
Kurashikishi, Okayama-ken 710-8602, Japan
Kawagoeshi, Saitama 350-8550, Japan
Bunkyoku, Tokyo 113-8677, Japan
Shinagawaku, Tokyo 141-0022, Japan
Lodz, 93-513, Poland
Wroclaw, 50-367, Poland
IlsandongGu GoyangSi, Gyeonggi-do 10408, South Korea
HwasunGun, Jeonnam-Gwangju S.M. City 58128, South Korea
GangnamGu, Seoul Teugbyeolsi 06351, South Korea
SeochoGu, Seoul Teugbyeolsi 06591, South Korea
Ankara, 06200, Turkey (Türkiye)
Dokuma, 07025, Turkey (Türkiye)
Bournemouth, BH7 7DW, United Kingdom