Clinical Trials List
2019-01-11 - 2024-12-31
Phase II
Recruiting2
Terminated5
ICD-10C82.90
Follicular lymphoma, unspecified, unspecified site
ICD-10C82
Follicular lymphoma
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
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Trial Applicant
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Sponsor
Pharmaceutical Research Associates Taiwan Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hui-Hua Hsiao 無
- Jeng-Shiun Du 無
- Ta-Chih Liu 無
- Hui-Ching Wang 無
- Shih-Feng Cho 無
- 蔡郁棻 無
- 唐世豪 無
- Yi-Chang Liu 無
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yao-Yu Hsieh 無
- Wei-Hong Cheng 無
- 蘇勇誠 無
- Huey-En Tzeng 無
- Tsu-Yi Chao 無
- TSU-YI CHAO 無
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Overall response rate (ORR) as Assessed by Independent Central Review [ Time Frame: up to 3 years ]
Secondary Outcome Measures :
Overall response rate (ORR) as Assessed by the Investigator [ Time Frame: up to 3 years ]
Duration of response (DOR) [ Time Frame: up to 3 years ]
Progression free survival (PFS) [ Time Frame: up to 3 years ]
Overall Survival (OS) [ Time Frame: up to 3 years ]
Complete Response Rate [ Time Frame: up to 3 years ]
Complete Metabolic Response Rate [ Time Frame: up to 3 years ]
Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: up to 3 years ]
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L) [ Time Frame: up to 3 years ]
Time to response (TTR) [ Time Frame: up to 3 years ]
Occurrence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: up to 3 years ]
Safety and Tolerability
Inclution Criteria
1. Histologically confirmed diagnosis of B-cell follicular lymphoma
2. ≥2 prior systemic treatments for follicular lymphoma.
3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
4. Disease progression after completion of most recent therapy or refractory disease.
5. Presence of measurable disease.
6. Availability of archival tissue confirming diagnosis.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
8. Adequate renal and hepatic function.
Exclusion Criteria
1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
2. Known central nervous system involvement by leukemia or lymphoma.
3. Evidence of transformation from follicular lymphoma to other aggressive histology.
4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
5. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate
6. Clinically significant cardiovascular disease.
7. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
8. Active fungal, bacterial or viral infection requiring systemic treatment.
9. History of severe bleeding disorder.
The Estimated Number of Participants
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Taiwan
14 participants
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Global
210 participants
