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Hodgkin LymphomaPhase 2HOVON164HLNCT05502250

Tislelizumab, Gemcitabine and Cisplatin for R/R Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission

A Phase 2 study testing gemcitabine, cisplatin and tislelizumab in people with Hodgkin Lymphoma, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 15 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial investigates the efficacy and safety of the drug tislelizumab in combination with chemotherapy as a treatment for patients with R/R HL. Tislelizumab is given in combination with chemotherapy (gemcitabine and cisplatin) followed by consolidation with tislelizumab alone. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
gemcitabine, cisplatin and tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
15 sitesin 3 countries
Study dates
14 Jul 2023to Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed classical HL (according to the latest version of the WHO classification).
  • Primary refractory to first line chemotherapy, or in first relapse after any polychemotherapy regimen (e.g. ABVD, baseline BEACOPP or escalated BEACOPP, or other induction regimens).
  • In case of relapse, the relapse must be histologically confirmed. In case histologic biopsy is not possible, at least confirmation of the relapse by fine needle aspirate (FNA) or sequential imaging is required.
  • Measurable disease, based on Lugano criteria 2014 [40]; i.e. CT scans showing at least 2 or more clearly demarcated lesions with a long axis ≥ 1.5 cm and a short axis diameter ≥ 1.0 cm, or 1 clearly demarcated lesion with a long axis ≥ 2.0 cm and a short axis diameter ≥ 1.0 cm. These lesions must be FDG-PET-positive.
  • Age 18-70 years inclusive.
  • WHO/ECOG Performance Status ≤ 1 (see appendix C).
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  • No major organ dysfunction, unless HL-related:
  • Total bilirubin < 1.5x ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome; in that case bilirubin may be elevated up to 3 x ULN).
  • ALT/AST < 3x ULN (unless due to lymphoma involvement of the liver; in that case ALT/AST may be elevated up to 5 x ULN).
  • GFR > 60 ml/min as estimated by the Cockcroft\&Gault formula.
  • Adequate BM function defined as:
  • Absolute neutrophil count ≥ 1.5x109/L, unless caused by diffuse bone marrow infiltration by the HL.
  • Platelets ≥ 75 x109/L, unless caused by diffuse bone marrow infiltration by the HL.
  • Hemoglobin must be ≥ 8 g/dL (5 mmol/L).
  • Resolution of toxicities from first-line therapy.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Negative pregnancy test at study entry.
  • Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through at least 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
  • Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
  • Written informed consent.
  • Patient is capable of giving informed consent.

Who cannot join

  • Previous treatment with an PD-1 or PDL-1 blocking agent.
  • Patients who have been using other investigational agents within at least 5 half lives or 4 weeks, whichever is longer, of the most recent agent used prior to start of protocol treatment.
  • Patients who were treated with myelosuppressive chemotherapy or biological therapy within at least 5 half lives or 4 weeks, whichever is longer, before start of protocol treatment.
  • Patients who were treated with steroids for more than 25 mg /day for at least 14 days before start of protocol treatment.
  • Patients receiving radiation therapy within 2 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists.
  • Prior allogeneic stem cell transplantation or solid organ transplantation.
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  • Peripheral neuropathy > grade 2.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Note: Patients with the following diseases are not excluded and may proceed to further screening:
  • Controlled Type I diabetes.
  • Hypothyroidism (provided it is managed with hormone replacement therapy only).
  • Controlled celiac disease.
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia).
  • Any other auto-immune disease that is not expected to recur due to the protocol treatment.
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.
  • Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
  • Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent).
  • Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption.
  • Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen).
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
  • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
  • Patients who have a history of another primary malignancy less than 2 years before study inclusion or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix.
  • Patients with any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
  • Patients with active HIV (unless viral load undetectable and CD4 counts within the normal range under antiretroviral therapy), active HBV (e.g. HBV DNA PCR positive or HBV surface antigen-positivity), or active HCV (e.g. HCV RNA detected). Patients with inactive HBV are eligible, but antiviral prophylaxis is obligatory.
  • Patients who have any severe and/or uncontrolled cardiovascular condition that could affect their participation in the study such as:
  • Known history of symptomatic congestive heart failure (NYHA III, IV), myocardial infarction ≤ 6 months prior to first study drug.
  • Evidence of current serious uncontrolled cardiac arrhythmia, angina pectoris, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • History of cerebrovascular accident ≤ 6 months before study treatment.
  • Patient who was administered a live vaccine ≤ 4 weeks before study treatment.
  • A history of severe hypersensitivity reactions to chimeric or humanized antibodies or platinum-based compounds.
  • Breast-feeding female patients.
  • Current participation in another clinical trial with medicinal products.
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Netherlands11 sites

  • NL-Amersfoort-MEANDERMC

    Amersfoort

  • NL-Amsterdam-AMC

    Amsterdam

  • NL-Arnhem-RIJNSTATE

    Arnhem

  • NL-Eindhoven-MAXIMAMC

    Eindhoven

  • NL-Goes-ADRZ

    Goes

  • NL-Groningen-UMCG

    Groningen

  • NL-Hoofddorp-SPAARNEGASTHUIS

    Hoofddorp

  • NL-Leeuwarden-MCL

    Leeuwarden

  • NL-Maastricht-MUMC

    Maastricht

  • NL-Rotterdam-ERASMUSMC

    Rotterdam

  • NL-Den Haag-HAGA

    The Hague

Other trials in Netherlands

Denmark3 sites

  • DK-Aarhus N-AUH

    Aarhus

  • DK-Copenhagen-RIGSHOSPITALET

    Copenhagen

  • DK-Odense-OUH

    Odense

Other trials in Denmark

Belgium1 site

  • BE-Bruxelles-STLUC

    Brussels

Other trials in Belgium

About this study

Official title: Tislelizumab Plus Gemcitabine and Cisplatin for Relapsed or Refractory Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission (TIGERR-HL). An Open Label Phase II Trial

This trial investigates the efficacy and safety of the drug tislelizumab in combination with chemotherapy as a treatment for patients with R/R HL. Tislelizumab is given in combination with chemotherapy (gemcitabine and cisplatin) followed by consolidation with tislelizumab alone. The study primary question is whether this strategy works as well as the standard treatment with intensive chemotherapy and autologous stem cell transplant.

Being tested
gemcitabine, cisplatin and tislelizumab
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine, cisplatin and tislelizumabDrug

    All patients will receive 2 cycles of gemcitabine and cisplatin (GP) + tislelizumab. Each cycle lasts 21 days. Treatment is given through an IV line on day 1 and 8.

    After 2 cycles a FDG-PET-CT scan will be performed. Patients who respond well will proceed with 2 additional cycles of GP + tislelizumab . Patients with insufficient response will stop with the study treatment and they will continue treatment according to local practice.

    After 4 cycles of GP + tislelizumab another FDG-PET-CT scan will be performed. If this scan shows that the disease is under control (metabolic complete remission) patients will proceed with 13 cycles of tislelizumab consolidation treatment (21 day cycles). Treatment is given on day 1 through an IV line.

Study groups in NCT05502250
Study groupRoleWhat they receive
Single-armExperimental4 cycles of gemcitabine and cisplatin (GP) + tislelizumab followed by 13 cycles of tislelizumab
Receives: Drug: gemcitabine, cisplatin and tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) probability at 2 years after registration. PFS is defined as time from registration to progression or death from any cause, whichever comes first.

    Single-arm

    Measured: Approximately up to 48 months following first patient enrollment

Secondary outcomes (8)

  1. Overall response rate (ORR: mCR and mPR rates) (as assessed by FDG-PET/CT) after 2 and 4 cycles of tislelizumab in combination with GP chemotherapy induction.

    Single-arm

    Measured: Approximately up to 28 months following first patient enrollment

  2. Rate of CTCAE grade 3/4 toxicities of tislelizumab in combination with GP chemotherapy.

    Single-arm

    Measured: Approximately up to 28 months following first patient enrollment

  3. Rate of CTCAE grade 2 to 4 immune related toxicities of tislelizumab in combination with GP chemotherapy.

    Single-arm

    Measured: Approximately up to 36 months following first patient enrollment

  4. Rate of CTCAE grade 3/4 toxicities of tislelizumab consolidation treatment.

    Single-arm

    Measured: Approximately up to 36 months following first patient enrollment

  5. Progression free survival (PFS) as time-to-event outcome.

    Single-arm

    Measured: Approximately up to 36 months following first patient enrollment

  6. Event free survival (EFS) defined as time from registration to start new HL treatment, progression or death from any cause, whichever comes first.

    Single-arm

    Measured: Approximately up to 84 months following first patient enrollment

  7. Disease free survival (DFS) defined as time from start of consolidation therapy to relapse or death from any cause, whichever comes first.

    Single-arm

    Measured: Approximately up to 84 months following first patient enrollment

  8. Overall survival (OS) defined as time from registration to death from any cause.

    Single-arm

    Measured: Approximately up to 84 months following first patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start14 Jul 2023
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm = 4 cycles of gemcitabine and cisplatin (GP) + tislelizumab followed by 13 cycles of tislelizumab
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502250
Sponsor's protocol ID
HO164
Other IDs
2022-502225-17
Acronym
HOVON164HL
Status last verified
Mar 2026
First submitted
25 May 2022
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine, cisplatin and tislelizumab in people with Hodgkin Lymphoma, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Netherlands, Denmark, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) probability at 2 years after registration. PFS is defined as time from registration to progression or death from any cause, whichever comes first. (time frame: Approximately up to 48 months following first patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05502250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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