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Clinical Trials in Denmark / NCT03517137
Active, not recruiting Phase 2

Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study

NCT03517137 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2019-08-01
Last updated
2026-09-11

Condition(s) studied

Advanced Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

Brentuximab Vedotin →Adriamycin →Vinblastine →Dacarbazine →Etoposide →Cyclophosphamide →Radiation Therapy

Brentuximab Vedotin: For PET positive (score of 4-5 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.8 mg/kg on day 1, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.2 mg/kg on day 1 and 15, every 4 weeks (5 cycles)

Adriamycin: For PET positive (score of 4-5 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 40 mg/m² on day 2, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 25 mg/m² on day 1 and 15, every 4 weeks (5 cycles)

Vinblastine: For PET negative (score of 1-3 following Deauville Criteria) patients: Vinblastine is administered as an IV infusion over a period of 15 minutes at 6mg/m² on day 1 and 15, every 4 weeks (5 cycles)

Dacarbazine: For PET positive (score of 4-5 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 250 mg/m² on day 3 and 4, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 375 mg/m² on day 1 and 15, every 4 weeks (5 cycles)

Etoposide: For PET positive (score of 4-5 following Deauville Criteria) patients: Etoposide is administered as an IV infusion over a period of 60 minutes at 150 mg/m² on day 2,3 and 4, every 3 weeks (6 cycles)

Cyclophosphamide: For PET positive (score of 4-5 following Deauville Criteria) patients: Cyclophosphamide is administered as an IV infusion over a period of 30 minutes at 1250 mg/m² on day 2, every 3 weeks (6 cycles)

Radiation Therapy: Patients with residual lymphoma mass(es) showing metabolic activity of Deauville score 4 or 5 after completion of chemotherapy will be offered consolidation radiotherapy.

Study summary

The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing regimens.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
ZNA Stuivenberg Antwerp Belgium
Universitair Ziekenhuis Antwerpen Edegem Belgium
U.Z. Leuven - Campus Gasthuisberg Leuven Belgium
University Hospitals Copenhagen - Rigshospitalet Copenhagen Denmark
Amsterdam UMC - Locatie AMC Amsterdam Netherlands
Deventer Ziekenhuis Deventer Netherlands
University Medical Center Groningen Groningen Netherlands
Medisch Centrum Leeuwarden-Zuid Leeuwarden Netherlands
Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove Leidschendam Netherlands
Radboudumc - Radboud University Medical Center Nijmegen Nijmegen Netherlands
Erasmus MC Rotterdam Netherlands
Maria Sklodowska Curie National Institute of Oncology - National Research Institute Warsaw Poland
Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa Lisbon Portugal
National Cancer Institute Bratislava Slovakia
Hospital Duran i Reynals (Institut Catala D'Oncologia) L'Hospitalet de Llobregat Spain
Complejo Hospitalario de Navarra Pamplona Spain

On this site

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More European Organisation for Research and Treatment of Cancer - EORTC trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03517137 on ClinicalTrials.gov ↗ ← All trials in Denmark