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Monoclonal Antibodies

Tislelizumab for Hodgkin's Lymphoma (TIRHOL Trial)

Phase 2
Waitlist Available
Led By Herve Ghesguieres
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has received at least 1 prior systemic regimen for 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

TIRHOL Trial Summary

This trial will test whether the drug tislelizumab is effective in treating people with a certain type of cancer that has come back or has not responded to other treatments.

Who is the study for?
This trial is for people with classical Hodgkin lymphoma that has come back or hasn't responded to treatment. They should have tried a stem cell transplant or at least one systemic therapy and not be candidates for new transplants. Participants need measurable disease, good physical function (ECOG 0-1), and no history of certain autoimmune diseases or prior treatments targeting specific immune pathways.Check my eligibility
What is being tested?
The study tests the effectiveness of tislelizumab in those with relapsed/refractory classical Hodgkin lymphoma. The main goal is to see how well patients respond to this drug according to established response criteria, as judged by the investigator overseeing the trial.See study design
What are the potential side effects?
Tislelizumab may cause immune-related side effects such as inflammation in various organs, potential infusion reactions during administration, fatigue, skin issues, and could possibly worsen pre-existing autoimmune conditions.

TIRHOL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had at least one treatment for classical Hodgkin lymphoma.
Select...
My Hodgkin lymphoma has returned or didn't respond to the last treatment.
Select...
My cancer returned or didn't respond after initial treatment, and I haven't had a stem cell transplant.
Select...
My condition worsened or didn't improve after a stem cell transplant using my own cells.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have at least one cancerous node or lesion that is visible and measurable on a PET scan.
Select...
My condition worsened or did not improve after a stem cell transplant.
Select...
I am not eligible for a stem cell transplant using my own or a donor's cells.
Select...
I am not eligible for more bone marrow or stem cell transplants.
Select...
My Hodgkin lymphoma has returned or is not responding to treatment.

TIRHOL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Complete Response Rate (CRR)
Duration of Response (DOR)
Number of participants Experiencing Adverse Events (AEs)
+2 more

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843
31%
Anaemia
24%
Weight decreased
17%
Cough
16%
Decreased appetite
16%
Constipation
16%
Pyrexia
15%
Aspartate aminotransferase increased
15%
Nausea
14%
Hypoalbuminaemia
13%
Fatigue
13%
Alanine aminotransferase increased
13%
Diarrhoea
12%
Hypothyroidism
12%
Hyponatraemia
11%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Pruritus
10%
Dyspnoea
9%
Arthralgia
9%
Dysphagia
9%
Hypokalaemia
9%
Rash
8%
Insomnia
7%
Hyperglycaemia
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Productive cough
6%
Malaise
5%
Hypertension
5%
White blood cell count increased
5%
Hypoproteinaemia
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Abdominal pain upper
4%
Nasopharyngitis
4%
Leukopenia
4%
Hypotension
4%
Stomatitis
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Haemoptysis
4%
Blood creatine phosphokinase increased
4%
Cancer pain
4%
Abdominal distension
4%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Myalgia
3%
Upper respiratory tract infection
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Dysphonia
3%
Hyperthyroidism
3%
C-reactive protein increased
3%
Hyperkalaemia
2%
Neutrophil count decreased
2%
Oesophageal obstruction
2%
Upper gastrointestinal haemorrhage
2%
Hyperuricaemia
2%
Hypochloraemia
2%
Thrombocytopenia
1%
Oesophageal fistula
1%
General physical health deterioration
1%
Peripheral sensory neuropathy
1%
Tumour pain
1%
Sepsis
1%
Pleural effusion
1%
Multiple organ dysfunction syndrome
1%
Oesophagomediastinal fistula
1%
Hypercalcaemia
1%
Oesophageal stenosis
1%
Pneumonia aspiration
1%
Type 1 diabetes mellitus
1%
Immune-mediated myositis
1%
Immune-mediated lung disease
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Neutropenia
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tislelizumab
Investigator Chosen Chemotherapy (ICC)

TIRHOL Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT
Group II: Cohort 1Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260

Find a Location

Who is running the clinical trial?

Lymphoma Study AssociationOTHER
39 Previous Clinical Trials
13,843 Total Patients Enrolled
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,768 Total Patients Enrolled
Herve GhesguieresPrincipal InvestigatorLymphoma Study Association

Media Library

Tislelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04318080 — Phase 2
Hodgkin's Lymphoma Clinical Trial 2023: Tislelizumab Highlights & Side Effects. Trial Name: NCT04318080 — Phase 2
Tislelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318080 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many persons are participating in this trial at present?

"This clinical trial has closed its recruitment period and is no longer accepting patients. First posted on August 20th 2020, the study was last updated on November 14th 2022. However, there are 1725 other trials seeking individuals with classical hodgkin's lymphoma and 105 studies involving Tislelizumab currently recruiting participants."

Answered by AI

Are there precedential studies that have incorporated Tislelizumab?

"Tislelizumab was first investigated at Uniwersyteckie Centrum Kliniczne in 2017, and 11 trials have been successfully completed. Currently, there are 105 active studies recruiting patients; particularly concentrated in Detroit, Michigan."

Answered by AI

Is Tislelizumab a reliable treatment option for patients?

"Our Power team rated the safety of Tislelizumab as a 2 due to Phase 2 trial data which suggests some degree of security but no evidence for efficacy."

Answered by AI

Is this trial the initial foray into such research?

"At present, there are 105 live experiments involving tislelizumab that span 45 countries and 426 cities. The first such trial was conducted in 2017 by BeiGene which included 805 participants and successfully completed Phase 3 approval for its drug. Since then, 11 more studies have been performed with the same medication."

Answered by AI

Is this scientific investigation still recruiting participants?

"Currently, this trial is not accepting candidates. Originally published on August 20th 2020 and last edited November 14th 2022, interested parties will be unable to participate in the study at this time. However, there are 1,725 clinical trials actively recruiting participants with classical Hodgkin's lymphoma and 105 studies utilizing Tislelizumab that still have open positions."

Answered by AI

How many places are presently overseeing this trial?

"This clinical trial is being conducted from multiple sites, including the Karmanos Cancer Institute in Detroit Michigan, Huntsman Cancer Center at University of Utah located in Westchester New york and University of TN Medical Centre based out of Basking Ridge Utah. Additionally, there are an additional 10 other trial locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
2020. "Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318080.
~10 spots leftby Apr 2025
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