Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
NCT ID NCT03517137
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
This phase 2 trial tests whether adjusting treatment based on a very early PET scan can improve outcomes and reduce side effects for people with advanced Hodgkin lymphoma. Participants receive brentuximab vedotin plus chemotherapy, with the regimen modified according to how well the cancer responds on the early scan. Researchers will track progression-free survival and overall survival to see if this personalized approach works better than standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin combined with chemotherapy drugs Adriamycin, vinblastine, and dacarbazine
- What this could lead to
- If successful, this approach could tailor treatment intensity to each patient's early response, potentially improving cure rates while sparing others from unnecessary side effects.
- What could go wrong
- The strategy might not improve outcomes compared to standard chemotherapy, and adjusting treatment based on early scans could lead to under- or over-treatment. As a phase 2 trial, it cannot prove superiority.
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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
-
150 people
The number who actually took part.
- Started
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Aug 2019
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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 60 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: * Previously untreated, histologically proven classical Hodgkin lymphoma; * Staged by PET with diagnostic-quality CT (i.v. contrast). * Clinical stages according to Lugano 2014 and based on FDG/PET CT: * Stage IIB with large mediastinal mass \> 1/3 max transverse diameter thorax and/or extranodal lesion(s) * Stage III - IV * Consent to participation in translational research: * Archival tumor tissue available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block). * Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment. * Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment. * Absence of any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy * Symptomatic neurologic disease compromising normal activities of daily living or requiring medications * Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 4.0 * Any of the following cardiovascular conditions or values: within 6 months before registration: * A left-ventricular ejection fraction \<50 percent (at registration) * New York Heart Association (NYHA) Class III or IV heart failure. * Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * symptomatic coronary heart disease (stable angina pectoris is allowed) * severe uncontrolled hypertension within 2 years before registration * Myocardial infarction * Patients with poorly controlled diabetes mellitus (HbA1c \> 7.5 percent or a fasting blood sugar \> 200 mg/dL). * Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration. * Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients). Note: HBsAg-/HBV DNA - patients are eligible; patients who are seropositive due to vaccination are eligible * Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer. * Previous treatment with anti CD30 antibodies * Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients. * Concurrent anti-cancer treatment or use of any investigational agent(s)
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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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Amsterdam UMC - Locatie AMC
Amsterdam, 1105, Netherlands
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Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
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Deventer Ziekenhuis
Deventer, 7400, Netherlands
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Erasmus MC
Rotterdam, 3015, Netherlands
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Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove
Leidschendam, 2262, Netherlands
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Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, 08908, Spain
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Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa
Lisbon, 1099, Portugal
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Maria Sklodowska Curie National Institute of Oncology - National Research Institute
Warsaw, 02781, Poland
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Medisch Centrum Leeuwarden-Zuid
Leeuwarden, 8934, Netherlands
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National Cancer Institute
Bratislava, 833, Slovakia
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Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, 6525, Netherlands
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U.Z. Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
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Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
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University Hospitals Copenhagen - Rigshospitalet
Copenhagen, 2100, Denmark
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University Medical Center Groningen
Groningen, 9713, Netherlands
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ZNA Stuivenberg
Antwerp, 2060, Belgium
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