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

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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

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE March 23, 2020
Last Update Posted Date July 7, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
  • 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
  • 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
  • Number of participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]
  • Number of participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title  ICMJE A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Classical Hodgkin Lymphoma
Intervention  ICMJE Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Name: BGB-A317
Study Arms  ICMJE
  • 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
    Intervention: Drug: Tislelizumab
  • 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
    Intervention: Drug: Tislelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04318080
Other Study ID Numbers  ICMJE BGB-A317-210
2019-002105-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Lymphoma Study Association
Investigators  ICMJE
Principal Investigator: Herve Ghesguieres Lymphoma Study Association
PRS Account BeiGene
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP