Phase
Condition
Neoplasms
Treatment
BGB-11417
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Confirmed diagnosis of only one of the following: Cohort A a. Marginal Zone Lymphoma i. R/R extranodal, splenic or nodal disease defined as disease that has relapsedafter, or been refractory to, ≥ 1 line of anti-CD20 antibody-basedchemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy forMZL is available per investigator's assessment. ii. Active disease requiring treatment. b. Follicular Lymphoma i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors ofhematopoietic and lymphoid tissue) and defined as disease that has relapsed after,or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available perinvestigator's assessment. ii. Active disease requiring treatment. c. Diffuse Large B-cell Lymphoma i. R/R DLBCL defined as disease that relapsed after, or been refractory to, at leastone line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles,and no effective standard therapy for DLBCL is available per investigator'sassessment. ii. Active disease requiring treatment. d. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Cohort A that has transformed into a moreaggressive lymphoma. Patients with transformation from CLL or SLL (Richter'stransformation) are not eligible for Cohort A. ii. Active disease requiring treatment. Cohorts B and C a. CLL/SLL diagnosis that meets the International Workshop on Chronic LymphocyticLeukemia (IWCLL) criteria: i. R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standardtherapy is available per investigator's assessment. ii. Requiring treatment based on IWCLL criteria.
Measurable disease by computed tomography/magnetic resonance imaging, defined as:
CLL: At least 1 lymph node > 1.5 centimeters (cm) in longest diameter andmeasurable in 2 perpendicular dimensions. For Cohort B, participants should notmeet with the definition of high tumor burden, which is required forparticipants enrolled in Cohort C.
DLBCL, FL, MZL, SLL: At least 1 lymph node > 1.5 cm in longest diameter OR 1extranodal lesion > 1.0 cm in the longest diameter, measurable in 2perpendicular dimensions. For MZL isolated splenomegaly is considered toindicate measurable disease for this study. For SLL, participants in Cohort Bshould not meet with the definition of high tumor burden, which is required forparticipants enrolled in Cohort C.
Exclusion
Key Exclusion Criteria:
Prior malignancy (other than the disease under study) within the past 2 years,except for curatively treated basal or squamous cell skin cancer, superficialbladder cancer, carcinoma in situ of the cervix or breast, or localized Gleasonscore ≤ 6 prostate cancer.
Underlying medical conditions that, in the investigator's opinion, will render theadministration of study drug hazardous or obscure the interpretation of safety orefficacy results.
Known central nervous system involvement by lymphoma/leukemia.
Known plasma cell neoplasm, prolymphocytic leukemia, history of or currentlysuspected Richter's syndrome.
Prior autologous stem cell transplant unless ≥ 3 months after transplant; or priorchimeric cell therapy unless ≥ 6 months after cell infusion.
Prior allogeneic stem cell transplant.
Study Design
Study Description
Connect with a study center
Peking University First Hospital
Beijing, Beijing Municipality 100034
ChinaSite Not Available
Peking University Peoples Hospital
Beijing, Beijing Municipality 100044
ChinaSite Not Available
Peking University First Hospital
Beijing 1816670, Beijing Municipality 2038349 100034
ChinaSite Not Available
Peking University Peoples Hospital
Beijing 1816670, Beijing Municipality 2038349 100044
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
Shenzhen Peoples Hospital
Shenzhen, Guangdong 518020
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935 510060
ChinaSite Not Available
Shenzhen Peoples Hospital
Shenzhen 1795565, Guangdong 1809935 518020
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520 450000
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430030
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaSite Not Available
Hunan Cancer Hospital
Changsha 1815577, Hunan 1806691 410013
ChinaSite Not Available
First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260 215006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang 1800163, Jiangxi 1806222 330006
ChinaSite Not Available
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality 200032
ChinaSite Not Available
Affiliated Zhongshan Hospital of Fudan University
Shanghai 1796236, Shanghai Municipality 1796231 200032
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaSite Not Available

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