Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20201517 | Registry Identifier | ChinaDrugTrials |
Not provided
Not provided
Not provided
Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab | Experimental | Tislelizumab monotherapy for up to 45 months |
|
| Salvage chemotherapy | Experimental | Salvage chemotherapy for up to 45 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200 mg administered via intravenous (IV) infusion once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) by Investigator | Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first | Up to 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) by Investigator | The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first | Up to 45 months |
| Overall Response Rate (ORR) by Investigator |
Not provided
Key Inclusion Criteria:
1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and
Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.
2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xia Zhao, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Quanzhou First Affliated Hospital of Fujian Medical University |
BeiGene 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.
BeiGene 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 BeiGene 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
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Salvage Chemotherapy | Drug | Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone) |
|
The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)
| Up to 45 months |
| Rate of Complete Response (CR) by Investigator | The proportion of participants who achieves a best overall response of CR | Up to 45 months |
| Time to Response (TTR) by Investigator | Time from the date of randomization to the time the response criteria are first met | Up to 45 months |
| Overall survival (OS) | Defined as the time from the date of randomization to the date of death due to any reason | Up to 45 months |
| Number of participants experiencing Adverse Events (AEs) | Up to 45 months |
| Number of participants experiencing Serious Adverse Events (SAEs) | Up to 45 months |
| Quanzhou |
| Fujian |
| 362000 |
| China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130021 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |