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

BeiGene

Status and phase: Active, not recruiting; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04318080

2019-002105-22 (EudraCT Number)

BGB-A317-210

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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)

Treatment:

Drug: Tislelizumab

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab