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

BeiGene

Status and phase: Completed; 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

This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).

2. Participants had either:

   • Relapsed cHL, defined as disease progression after a partial response (PR) or complete response (CR) to their most recent therapy; or
   • Refractory cHL, defined as failure to achieve PR or CR to their most recent therapy.

   Participants were assigned to one of two cohorts based on the following:

   Cohort 1: Participants who were relapsed or refractory after prior autologous hematopoietic stem cell transplantation (HSCT):

   1. Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
   2. Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).

   Cohort 2: Participants who were relapsed or refractory to salvage chemotherapy and had not received prior HSCT:

   1. Were not considered candidates for autologous or allogeneic HSCT.
   2. Had received at least one prior systemic therapy regimen for cHL.

3. Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.

4. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, indicating full activity or restricted activity but capable of self-care.

Key Exclusion Criteria:

1. Participants had nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
2. Participants had received prior allogeneic HSCT.
3. Participants had received prior therapy targeting immune checkpoint pathways, including programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
4. Participants had active autoimmune disease or a history of autoimmune disease with potential to relapse.

Note: Additional inclusion and exclusion criteria defined in the protocol may have applied.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.

Treatment:

Drug: Tislelizumab

Cohort 2

Experimental group

Description:

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.

Treatment:

Drug: Tislelizumab