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| ID | Type | Description | Link |
|---|---|---|---|
| CT-2023-CTN-05421-1 | Other Identifier | Australia Clinical Trial Number | |
| CTR20231287 | Other Identifier | ChinaDrugTrials | |
| 2025-521600-21-00 | EU Trial (CTIS) Number |
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This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL) | Experimental | Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], marginal zone lymphoma [MZL], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day. |
|
| Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden | Experimental | Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day. |
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| Part 2 (Cohort A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL | Experimental | Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy. |
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| Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL | Experimental | Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-21447 | Drug | BGB-21447 will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with dose limiting toxicities (DLTs) | Number of participants with dose limiting toxicities, as defined in the study protocol. | Up to approximately 1 month |
| Number of participants with adverse events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). | From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months |
| Number of participants with Tumor Lysis Syndrome (TLS) | TLS will be determined via laboratory values and assessed by the investigator. In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death. | From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-21447 | Up to approximately 8 weeks | |
| Area under the curve from time 0 to the last sampling time point within the dose interval (AUC0-t) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
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Inclusion Criteria
Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:
Cohort A1 and Cohort A2:
R/R DLBCL (for Cohort A1 and Cohort A2.1)
R/R FL (for Cohort A1 and Cohort A2.2)
R/R MZL (for Cohort A1 and Cohort A2.2)
Transformed B-cell NHL (for Cohort A1 only)
Richter's transformation to DLBCL (for Cohort A1 only)
Measurable disease by computed tomography/magnetic resonance imaging.
Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital Johns Hopkins Medicine | Washington D.C. | District of Columbia | 20016 | United States | ||
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| Area under the curve from time 0 extrapolated to infinity time (AUCinf) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
| Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
| Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
| Apparent oral clearance (CL/F) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
| Apparent volume of distribution (Vz/F) After a Single Dose of BGB-21447 | Up to approximately 8 weeks |
| Steady state maximum observed plasma concentration (Cmax,ss) of BGB-21447 | Up to approximately 8 weeks |
| Steady state pre-dose trough concentration (Ctrough,ss) of BGB-21447 | Up to approximately 8 weeks |
| Steady state area under the curve from time 0 to the quantifiable concentration (AUClast,ss) of BGB-21447 | Up to approximately 8 weeks |
| Steady state time to reach maximum observed plasma concentration (Tmax,ss) of BGB-21447 | Up to approximately 8 weeks |
| Overall response rate (ORR) | Defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma. | Up to approximately 24 months |
| Duration of Response (DOR) | Defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first. | Up to approximately 24 months |
| Time to response (TTR) | Defined as the time from treatment initiation to the first documentation of response. | Up to approximately 24 months |
| Part 2: Progression-free survival (PFS) | Defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first. | Up to approximately 24 months |
| University of Iowa Hospitals and Clinics |
| Iowa City |
| Iowa |
| 52242-1009 |
| United States |
| Mission Cancer and Blood | Waukee | Iowa | 50263 | United States |
| Sidney Kimmel Comprehensive Cancer At Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island | Mineola | New York | 11501 | United States |
| Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health | New York | New York | 10016-2708 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105-2108 | United States |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | NSW 2148 | Australia |
| Pindara Private Hospital | Benowa | Queensland | QLD 4217 | Australia |
| Mater Cancer Care Centre | South Brisbane | Queensland | QLD 4101 | Australia |
| Monash Health | Clayton | Victoria | VIC 3168 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | WA 6009 | Australia |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Yichang Central Peoples Hospitaljiangnan Branch | Yichang | Hubei | 443001 | China |
| The First Peoples Hospital of Changzhou | Changzhou | Jiangsu | 213000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| The First Affiliated Hospital of Nanchang University Branch Xianghu | Nanchang | Jiangxi | 332000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Linyi Peoples Hospital | Linyi | Shandong | 276000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | 300020 | China |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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