BRENTUXIMAB VEDOTIN for Advanced stage Hodgkin lymphoma

Inclusion criteria

• {"criterion_text":"- Previously untreated, histologically proven classical Hodgkin lymphoma\n- 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\n- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations\n- 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) (GHSG) - Stage III - IV\n- Participation in translational research is mandatory and therefore patient must consent to additional blood samples at multiple time points in the study. In addition, sufficient tissue must be available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block)\n- Age ≥18 and ≤60\n- WHO performance status 0-2\n- Patient demonstrates adequate organ function as defined in the protocol\n- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment\n- Patients of childbearing / reproductive potential should use two birth control methods, as defined by the investigator, from the time of signing the informed consent form, and throughout the entire study and for 6 months after the last dose of treatment\n- 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"}

Exclusion criteria

• {"criterion_text":"- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy\n- Myocardial infarction\n- Patients with poorly controlled diabetes mellitus (HbA1c > 7.5 % or a fasting blood sugar > 200 mg/dL)\n- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration\n- Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients)\n- Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer\n- Previous treatment with anti CD30 antibodies\n- Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs\n- Concurrent anti-cancer treatment or use of any investigational agent(s)\n- Symptomatic neurologic disease compromising normal activities of daily living or requiring medications\n- Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 5.0\n- Any of the following cardiovascular conditions or values: - within 6 months before registration\n- A left-ventricular ejection fraction <50%\n- New York Heart Association (NYHA) Class III or IV heart failure\n- 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\n- symptomatic coronary heart disease (stable angina pectoris is allowed)\n- severe uncontrolled hypertension defined as blood pressure (BP) >150/100 mmHg despite optimal antihypertensive treatment - within 2 years before registration"}

Primary endpoints

• {"endpoint_text":"- Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient). The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause.","definition_or_measurement_approach":"Modified progression-free survival rate at 2 years estimated from Kaplan-Meier curve of modified PFS (mPFS). Events: progression/relapse; start of new treatment for classical Hodgkin lymphoma when not in complete response after completing protocol treatment; death from any cause."}

Secondary endpoints

• {"endpoint_text":"- FDG-PET result (positive/negative) after 1 cycle of BrAVD (central assessment)","definition_or_measurement_approach":"FDG-PET result (positive/negative) after 1 cycle of BrAVD assessed centrally; includes assessment of FDG-PET negativity (Deauville score 1-3)."}
• {"endpoint_text":"- Response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT","definition_or_measurement_approach":"Response determined per Lugano criteria at end of protocol treatment using FDG-PET/CT."}
• {"endpoint_text":"- Progression-free survival (where progression, relapse and death from any cause are considered events)","definition_or_measurement_approach":"Time from start of treatment to progression, relapse or death from any cause."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Time from start of treatment to death from any cause (overall survival)."}
• {"endpoint_text":"- Safety and tolerability","definition_or_measurement_approach":"Assessment of safety and tolerability of BV-containing regimens and radiotherapy (adverse events, CTCAE)."}
• {"endpoint_text":"- Response according to RECIL 2017","definition_or_measurement_approach":"Response assessment according to RECIL 2017 criteria."}

Belgium

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

17-10-2024

Processing Time Days

16

Number Of Sites

3

Number Of Participants

1

Denmark

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

22

Number Of Sites

1

Number Of Participants

1

Portugal

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

17

Number Of Sites

1

Number Of Participants

1

Spain

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

22-10-2024

Processing Time Days

21

Number Of Sites

2

Number Of Participants

1

Netherlands

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

15

Number Of Sites

7

Number Of Participants

1

Poland

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

08-11-2024

Processing Time Days

38

Number Of Sites

1

Number Of Participants

1

Slovakia

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

17

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

European Organisation For Research And Treatment Of Cancer

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium

Third parties

• {"country":"Netherlands","full_name":"OncoDrugConsult B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"IMP labeling and supply + Sample shipment","organisation_type":"Pharmaceutical company"}