Clinical Trials /

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT04318080

Description:

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.

Related Conditions:
  • Classical Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
  • Official Title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-210
  • SECONDARY ID: 2019-002105-22
  • NCT ID: NCT04318080

Conditions

  • Classical Hodgkin Lymphoma

Interventions

DrugSynonymsArms
TislelizumabBGB-A317Cohort 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalParticipants 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
  • Tislelizumab
Cohort 2ExperimentalParticipants with relapsed or refractory cHL who have received at least 2 prior systemic chemotherapy regimens and failed to achieve a response or progressed after brentuximab vedotin, and are not candidates for autologous or allogeneic HSCT
  • Tislelizumab

Eligibility 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:

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

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

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

             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

               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 , 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 30 months
Safety Issue:
Description:ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary Outcome Measures

Measure:Complete Response Rate (CRR)
Time Frame:Up to 30 months
Safety Issue:
Description:Defined as the proportion of patients who achieve the best response of complete response (CR)
Measure:Duration of Response (DOR)
Time Frame:Up to 30 months
Safety Issue:
Description:Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first
Measure:Time to Response (TTR)
Time Frame:Up to 30 months
Safety Issue:
Description:Time from the date of the first dose of tislelizumab to the time the response criteria are first met
Measure:Number of participants Experiencing Adverse Events (AEs)
Time Frame:Up to 30 days posttreatment (Treatment duration is 30 months)
Safety Issue:
Description:
Measure:Number of participants Experiencing Serious Adverse Events (SAEs)
Time Frame:Up to 30 days posttreatment (Treatment duration is 30 months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Last Updated

June 21, 2021