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Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (TIRHOL)

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: NCT04318080
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Lymphoma Study Association
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Tislelizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: Tislelizumab Monotherapy Post HSCT
Participants with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after autologous hematopoietic stem cell transplantation (HSCT) and failed to achieve a response or progressed after brentuximab vedotin
 Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Name: BGB-A317
Experimental: Cohort 2: Tislelizumab Monotherapy Post Chemotherapy
Participants with relapsed or refractory cHL who have received at least 2 prior systemic chemotherapy regimens, and are not candidates for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy (did not achieve a Partial Response (PR) or Complete Response (CR)) and failed to achieve a response or progressed after brentuximab vedotin
 Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Name: BGB-A317


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 30 months ]
    ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 30 months ]
    Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first

  2. Time to Response (TTR) [ Time Frame: Up to 30 months ]
    Time from the date of the first dose of tislelizumab to the time the response criteria are first met

  3. Number of participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]
  4. Number of participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]

Eligibility Criteria
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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 diagnosis of relapsed or refractory cHL

  2. Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria:

    i) Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin

    ii) Cohort 2: Relapsed or refractory to salvage chemotherapy, including brentuximab vedotin, and has not received prior autologous or allogeneic HSCT

    1. Is not a candidate for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy (did not achieve a PR or CR)
    2. Has received at least 2 prior systemic chemotherapy regimens for cHL and failed to achieve a response or progressed after brentuximab vedotin
  3. Measurable disease defined as ≥ 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter
  4. Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

  1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
  2. Prior allogeneic hematopoietic stem cell transplantation
  3. Prior therapy targeting PD-1 or PD-L1, anti-PD-L2, or anti CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) agent
  4. Active autoimmune disease or history of autoimmune disease that may relapse

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

Contacts and Locations
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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): NCT04318080


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

Locations
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Australia, Victoria
Saint Vincent's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
BeiGene
Lymphoma Study Association
Investigators
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Principal Investigator: Herve Ghesguieres Lymphoma Study Association
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04318080    
Other Study ID Numbers: BGB-A317-210
2019-002105-22 ( EudraCT Number )
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
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