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

Primary Purpose

Classical Hodgkin Lymphoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karmanos Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • University of TN Medical Center
  • Huntsman Cancer Center, University of Utah
  • Border Medical Oncology
  • Royal Adelaide Hospital
  • Monash Medical Center
  • Saint Vincent's Hospital Melbourne
  • Institut Jules Bordet
  • CHU de Liège - Domaine Universitaire du Sart Tilman
  • CHU UCL Namur - Site Godinne
  • Institut Gustave Roussy- Cancer Campus Grand Paris
  • Institut d'Hematologie de Basse-Normandie
  • Hopital Henri-Mondor
  • CHU Dijon Bourgogne
  • CHD de Vendee
  • CH de Versailles - Hopital Andre Mignot
  • CHRU de Lille- Hôpital Claude Huriez
  • CHU de Limoges - Hopital Dupuytren
  • CHU de Montpellier
  • CHU de Nantes
  • Hopital Saint-Louis
  • CHU de Bordeaux Hopital Haut-Leveque
  • CHU Lyon-Sud
  • Centre Henri-Becquerel
  • CHRU de Strasbourg
  • IUCT Oncopole
  • CHU Brabois
  • Hospital Oncologico-PR Med Ctr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm 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)

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

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary Outcome Measures

Complete Response Rate (CRR)
Defined as the proportion of participants who achieve the best response of complete response (CR)
Duration of Response (DOR)
Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first. Only participants who have achieved an overall response will be included in the analysis.
Time to Response (TTR)
Time from the date of the first dose of tislelizumab to the time the response criteria are first met. Only participants who have achieved an overall response will be included in the analysis.
Number of participants Experiencing Adverse Events (AEs)
Number of participants Experiencing Serious Adverse Events (SAEs)

Full Information

First Posted
March 20, 2020
Last Updated
August 23, 2023
Sponsor
BeiGene
Collaborators
Lymphoma Study Association
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1. Study Identification

Unique Protocol Identification Number
NCT04318080
Brief Title
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Acronym
TIRHOL
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
Collaborators
Lymphoma Study Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm 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)
Arm Title
Cohort 2
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg intravenously (IV) every 3 weeks (Q3W)
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Complete Response Rate (CRR)
Description
Defined as the proportion of participants who achieve the best response of complete response (CR)
Time Frame
Up to 30 months
Title
Duration of Response (DOR)
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. Only participants who have achieved an overall response will be included in the analysis.
Time Frame
Up to 30 months
Title
Time to Response (TTR)
Description
Time from the date of the first dose of tislelizumab to the time the response criteria are first met. Only participants who have achieved an overall response will be included in the analysis.
Time Frame
Up to 30 months
Title
Number of participants Experiencing Adverse Events (AEs)
Time Frame
Up to 30 days posttreatment (Treatment duration is 30 months)
Title
Number of participants Experiencing Serious Adverse Events (SAEs)
Time Frame
Up to 30 days posttreatment (Treatment duration is 30 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed diagnosis of relapsed or refractory cHL 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) Has failed to achieve a response or progressed after autologous HSCT 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 Is not a candidate for autologous or allogeneic HSCT Has received at least 1 prior systemic regimen for cHL 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 Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1 Key Exclusion Criteria: Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma Prior allogeneic hematopoietic stem cell transplantation Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways Active autoimmune disease or history of autoimmune disease that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herve Ghesguieres
Organizational Affiliation
Lymphoma Study Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Bergen
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Monmouth Junction
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Nassau
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Westchester
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
University of TN Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Huntsman Cancer Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Center
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Saint Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur - Site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Institut Gustave Roussy- Cancer Campus Grand Paris
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Institut d'Hematologie de Basse-Normandie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Henri-Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHD de Vendee
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH de Versailles - Hopital Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
CHRU de Lille- Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59307
Country
France
Facility Name
CHU de Limoges - Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU de Bordeaux Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Lyon-Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Henri-Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
IUCT Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hospital Oncologico-PR Med Ctr
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

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