Clinical trial NCT04318080: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
Collaborators: name: Lymphoma Study Association
First posted: 2020-03-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
   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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 30 months
Secondary outcomes:
measure: Complete Response Rate (CRR)
timeFrame: Up to 30 months
measure: Duration of Response (DOR)
timeFrame: Up to 30 months
measure: Time to Response (TTR)
timeFrame: Up to 30 months
measure: Number of participants Experiencing Adverse Events (AEs)
timeFrame: Up to 30 days posttreatment (Treatment duration is 30 months)
measure: Number of participants Experiencing Serious Adverse Events (SAEs)
timeFrame: Up to 30 days posttreatment (Treatment duration is 30 months)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
Study officials:
affiliation: Lymphoma Study Association
name: Herve Ghesguieres
role: PRINCIPAL_INVESTIGATOR
References: