New drug combo may replace harsh transplant for hodgkin lymphoma patients
NCT ID NCT05502250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called tislelizumab combined with chemotherapy for people whose Hodgkin lymphoma has returned or not responded to initial treatment. The goal is to see if this approach works as well as the standard intensive chemotherapy and stem cell transplant. About 75 adults with confirmed Hodgkin lymphoma will receive the drug combo, and those who achieve complete remission will continue on tislelizumab alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BE-Bruxelles-STLUC
Brussels, Belgium
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DK-Aarhus N-AUH
Aarhus, Denmark
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DK-Copenhagen-RIGSHOSPITALET
Copenhagen, Denmark
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DK-Odense-OUH
Odense, Denmark
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NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
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NL-Amsterdam-AMC
Amsterdam, Netherlands
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NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
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NL-Den Haag-HAGA
The Hague, Netherlands
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NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
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NL-Goes-ADRZ
Goes, Netherlands
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NL-Groningen-UMCG
Groningen, Netherlands
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NL-Hoofddorp-SPAARNEGASTHUIS
Hoofddorp, Netherlands
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NL-Leeuwarden-MCL
Leeuwarden, Netherlands
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NL-Maastricht-MUMC
Maastricht, Netherlands
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NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
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