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Closed (no longer recruiting)Last updated: 9 January 2024

TIRHOL: This phase II trial is trying to understand how effective a new targeted therapy is in Hodgkin's Lymphoma patients whose cancer has got worse or not responded to previous treatmentA Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Clinical summary

Summary

Patients with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after receiving either an autologous hematopoietic stem cell transplantation (HSCT) or at least 2 prior systemic chemotherapy regimens and are not candidates for autologous or allogeneic HSCT, will receive 200 mg intravenously (IV) every 3 weeks (Q3W)

Conditions

This trial is treating patients with Hodgkin's Lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

TIRHOL

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

BeiGene Australia Pty Ltd,Lymphoma Study Association

Scientific Title

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

Eligibility

Inclusion

  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

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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