Brentuximab vedotin for Classical Hodgkin lymphoma | Hodgkin lymphoma

Inclusion criteria

• {"criterion_text":"- Male or female patients 18 years or older up to 65 years of age"}
• {"criterion_text":"- Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care"}
• {"criterion_text":"- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse"}
• {"criterion_text":"- Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree 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"}
• {"criterion_text":"- ECOG performance status 0 to 2"}
• {"criterion_text":"- Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)"}
• {"criterion_text":"- No evidence of neuropathy grade ≥2"}
• {"criterion_text":"- Clinical laboratory values as specified below within 7 days before the first dose of study drug: Absolute neutrophil count ≥ 1,500/µL unless there is known hematologic/solid tumor marrow involvement; Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease; Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome; ALT or AST must be < 3 x the upper limit of the normal range; AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver; Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute; Hemoglobin must be ≥ 8g/dL"}

Exclusion criteria

• {"criterion_text":"- Lymphocyte predominant nodular Hodgkin’s lymphoma"}
• {"criterion_text":"- Prior treatment with brentuximab vedotin"}
• {"criterion_text":"- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug"}
• {"criterion_text":"- Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol"}
• {"criterion_text":"- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML"}
• {"criterion_text":"- Symptomatic neurologic disease compromising normal activities of daily living or requiring medic"}
• {"criterion_text":"- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2"}
• {"criterion_text":"- Known history of any of the following cardiovascular conditions: Myocardial infarction within 2 years of enrollment; 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; Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%"}
• {"criterion_text":"- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose"}
• {"criterion_text":"- Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment"}
• {"criterion_text":"- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin"}
• {"criterion_text":"- Known human immunodeficiency virus (HIV) positive (in case of Anti-HIV positive result patient cannot be included in the study)"}
• {"criterion_text":"- Known hepatitis B surface or core antigen-positive (HBsAg/ HBcAg). In case of Anti HBc positive result, DNA-HBV must be determined and negative result will allow patient inclusion. Known or suspected active hepatitis C infection. In case of Anti-HCV positive result, RNA-HCV must be determined and negative result will allow patient inclusion."}
• {"criterion_text":"- Focal radiation therapy within 30 days prior to study recruitment"}
• {"criterion_text":"- Major surgery within 28 days prior to randomization"}
• {"criterion_text":"- Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection"}

Primary endpoints

• {"endpoint_text":"- Treatment response based on Deauville scores 1, 2, 3 (Complete metabolic response) by PET-CT scan After the 3 first cycles of BV-ESHAP or ESHAP","definition_or_measurement_approach":"Assessment by PET-CT after 3 cycles; metabolic complete remission (mCR) defined as PET-CT negative, Deauville scores 1-3."}

Secondary endpoints

• {"endpoint_text":"- Two years Progression Free Survival (PFS): time from entry onto the study until lymphoma progression or death as a result of any cause","definition_or_measurement_approach":"Time from study entry until lymphoma progression or death from any cause; assessed up to 2 years."}
• {"endpoint_text":"- Two years Overall Survival (OS): time from entry onto the clinical trial until death as a result of any cause.","definition_or_measurement_approach":"Time from study entry until death from any cause; assessed up to 2 years."}
• {"endpoint_text":"- Duration of response (DOR): time from first documentation of CR or PR to disease progression or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from first documented complete or partial response to progression or death."}
• {"endpoint_text":"- Time to Progression (TTP): time from study entry until lymphoma progression or death as a result of lymphoma","definition_or_measurement_approach":"Time from study entry to lymphoma progression or death due to lymphoma."}
• {"endpoint_text":"- Time to Next Treatment (TTNT): time from the end of primary treatment until the onset of the next therapy","definition_or_measurement_approach":"Time from end of primary treatment to start of next therapy."}
• {"endpoint_text":"- Time to Next Treatment 2 (TTNT2): time from study enrollment to initiation of second line of therapy due to disease progression","definition_or_measurement_approach":"Time from study enrollment to initiation of a second-line therapy for progression."}
• {"endpoint_text":"- Overall response rate, complete response rate after the 3 first cycles of BV-ESHAP or ESHAP","definition_or_measurement_approach":"Assessment of overall response rate (ORR) and complete response (CR) after 3 cycles."}
• {"endpoint_text":"- Prognostic impact of metabolic tumor volume","definition_or_measurement_approach":"Evaluation of metabolic tumor volume (MTV) by baseline PET-CT and its association with outcomes (PFS, OS)."}
• {"endpoint_text":"- Quality of life of patients","definition_or_measurement_approach":"Patient-reported outcomes (PROs) assessing functional, emotional and social domains; assessed yearly up to 3 years during consolidation and follow-up."}
• {"endpoint_text":"- Safety and tolerability As assessed by type, frequency, and severity for AEs and relationship with study treatment of AEs Focusing on fertility (evaluated yearly up to 3 years from the end of treatmentand secondary malignancies (3 years follow up for secondary malignancies","definition_or_measurement_approach":"Safety assessed by type, frequency and severity of adverse events and relationship to study treatment; specific focus on fertility and secondary malignancies with annual evaluations up to 3 years post-treatment."}

Austria

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

12-11-2024

Processing Time Days

6

Number Of Sites

1

Number Of Participants

4

Croatia

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

57

Number Of Sites

1

Number Of Participants

1

Greece

Earliest CTIS Part Ii Submission Date

07-01-2025

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

15

Number Of Sites

2

Number Of Participants

3

Spain

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

15

Number Of Sites

23

Number Of Participants

141

Primary sponsor

Full Name

Fundacion Geltamo

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"Greece","full_name":"Optimapharm Greece Consulting Research Single Member S.A.","duties_or_roles":"1,5","organisation_type":"Pharmaceutical company"}
• {"country":"Croatia","full_name":"Croatian Cooperative Group For Hematologic Diseases","duties_or_roles":"1,5","organisation_type":"Patient organisation/association"}
• {"country":"Spain","full_name":"Evidenze Health Espana S.L.","duties_or_roles":"1,10,11,14,5,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Hospital Universitario De Salamanca","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Austria","full_name":"Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH","duties_or_roles":"1,5","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

• Optimapharm Greece Consulting Research Single Member S.A.
• Croatian Cooperative Group For Hematologic Diseases
• Evidenze Health Espana S.L.
• Alcura Health Espana S.A.
• Hospital Universitario De Salamanca
• Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH