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Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486391
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Tislelizumab Drug: Salvage Chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 26, 2024
Estimated Study Completion Date : March 26, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab
Tislelizumab monotherapy for up to 45 months
Drug: Tislelizumab
200 mg administered via intravenous (IV) infusion once every 3 weeks
Other Name: BGB-A317

Experimental: Salvage chemotherapy
Salvage chemotherapy for up to 45 months
Drug: Salvage Chemotherapy
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)




Primary Outcome Measures :
  1. Progression-free Survival (PFS) by Investigator [ Time Frame: Up to 45 months ]
    Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first


Secondary Outcome Measures :
  1. Duration of Response (DOR) by Investigator [ Time Frame: Up to 45 months ]
    The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first

  2. Overall Response Rate (ORR) by Investigator [ Time Frame: Up to 45 months ]
    The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)

  3. Rate of Complete Response (CR) by Investigator [ Time Frame: Up to 45 months ]
    The proportion of participants who achieves a best overall response of CR

  4. Time to Response (TTR) by Investigator [ Time Frame: Up to 45 months ]
    Time from the date of randomization to the time the response criteria are first met

  5. Overall survival (OS) [ Time Frame: Up to 45 months ]
    Defined as the time from the date of randomization to the date of death due to any reason

  6. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 45 months ]
  7. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 45 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and

  1. Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
  2. 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:

    1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
    2. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
    3. Prior therapies targeting PD-1 or PD-L1.
    4. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
    5. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
    6. Serious acute or chronic infection requiring systemic therapy.
    7. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486391


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
China, Fujian
Quanzhou First Hospital Affiliated to Fujian Medical University Recruiting
Quanzhou, Fujian, China, 362002
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 410013
China, Jilin
Jilin Cancer Hospital Recruiting
Changchun, Jilin, China, 130012
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Xia Zhao, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04486391    
Other Study ID Numbers: BGB-A317-314
CTR20201517 ( Registry Identifier: CDE )
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents