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TIRHOL: Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04318080
Collaborator
Lymphoma Study Association (Other)
100
Enrollment
35
Locations
2
Arms
43.3
Anticipated Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Actual Study Start Date :
Aug 20, 2020
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

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)

Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Names:
  • BGB-A317

    		•
    Experimental: Cohort 2

    Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT

    Drug: Tislelizumab
    200 mg intravenously (IV) every 3 weeks (Q3W)
    Other Names:
  • BGB-A317

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [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. Complete Response Rate (CRR) [Up to 30 months]

      Defined as the proportion of patients who achieve the best response of complete response (CR)

    2. Duration of Response (DOR) [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

    3. Time to Response (TTR) [Up to 30 months]

      Time from the date of the first dose of tislelizumab to the time the response criteria are first met

    4. Number of participants Experiencing Adverse Events (AEs) [Up to 30 days posttreatment (Treatment duration is 30 months)]

    5. Number of participants Experiencing Serious Adverse Events (SAEs) [Up to 30 days posttreatment (Treatment duration is 30 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

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

    1. Has failed to achieve a response or progressed after autologous HSCT

    2. Is not a candidate for additional autologous or allogeneic HSCT

    Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior autologous or allogeneic HSCT

    1. Is not a candidate for autologous or allogeneic HSCT

    2. Has received at least 1 prior systemic regimen for cHL

    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 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways

    4. Active autoimmune disease or history of autoimmune disease that may relapse

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karmanos Cancer Institute Detroit Michigan United States 48201
    2 Memorial Sloan Kettering Cancer Center Basking Ridge New Jersey United States 07920
    3 Memorial Sloan Kettering Cancer Center Bergen New Jersey United States 07645
    4 Memorial Sloan Kettering Cancer Center Monmouth Junction New Jersey United States 07748
    5 Memorial Sloan Kettering Cancer Center Commack New York United States 11725
    6 Memorial Sloan Kettering Cancer Center Nassau New York United States 11553
    7 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    8 Memorial Sloan Kettering Cancer Center Westchester New York United States 10604
    9 University of TN Medical Center Knoxville Tennessee United States 37920
    10 Huntsman Cancer Center, University of Utah Salt Lake City Utah United States 84112
    11 Border Medical Oncology Albury New South Wales Australia 2640
    12 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    13 Monash Medical Center Clayton Victoria Australia 3168
    14 Saint Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
    15 Institut Jules Bordet Bruxelles Belgium 1000
    16 CHU de Liège - Domaine Universitaire du Sart Tilman Liège Belgium 4000
    17 CHU UCL Namur - Site Godinne Yvoir Belgium 5530
    18 Institut Gustave Roussy- Cancer Campus Grand Paris Villejuif Val De Marne France 94805
    19 Institut d'Hematologie de Basse-Normandie Caen France 14033
    20 Hopital Henri-Mondor Créteil France 94010
    21 CHU Dijon Bourgogne Dijon France 21000
    22 CHD de Vendee La Roche-sur-Yon France 85925
    23 CH de Versailles - Hopital Andre Mignot Le Chesnay France 78157
    24 CHRU de Lille- Hôpital Claude Huriez Lille France 59307
    25 CHU de Limoges - Hopital Dupuytren Limoges France 87042
    26 CHU de Montpellier Montpellier France 34090
    27 CHU de Nantes Nantes France 44093
    28 Hopital Saint-Louis Paris France 75475
    29 CHU de Bordeaux Hopital Haut-Leveque Pessac France 33604
    30 CHU Lyon-Sud Pierre-Bénite France 69495
    31 Centre Henri-Becquerel Rouen France 76038
    32 CHRU de Strasbourg Strasbourg France 67098
    33 IUCT Oncopole Toulouse France 31059
    34 CHU Brabois Vandœuvre-lès-Nancy France 54511
    35 Hospital Oncologico-PR Med Ctr Rio Piedras Puerto Rico 00935

    Sponsors and Collaborators

    • BeiGene
    • Lymphoma Study Association

    Investigators

    • Principal Investigator: Herve Ghesguieres, Lymphoma Study Association

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04318080
    Other Study ID Numbers:
    • BGB-A317-210
    • 2019-002105-22
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease

    Study Results

    No Results Posted as of Dec 15, 2021