PREFer

Ki vehet részt

• Histologically confirmed first diagnosis of cHL
• Early-stage favorable cHL as assessed by all mandatory imaging examinations as outlined in section 5.1.2.3 of the protocol, i.e.stage I-II without risk factors: Large mediastinal mass; Extranodal involvement; Elevated erythrocyte sedimentation rate (ESR); Involvement of ≥ 3 nodal areas
• Age ≥ 18 and ≤ 75 years on the day of signing the patient information and informed consent form (ICF)
• Participants must be willing and capable of giving written informed consent prior to any trial-related activity
• Adequate blood count (except for cHL-related changes or functional disorders) obtained within 7 days prior to signing the ICF: Hemoglobin (Hb) ≥ 9 g/dL (without red-blood-cell transfusion within the prior 7 days) ; Platelet concentration ≥ 100 x 109/L (without platelet transfusion within the prior 7 days) ; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to signing the ICF
• Estimated life expectancy > 3 months
• Contraception a) Females of childbearing potential must have a negative urine or serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test within 7 days prior to signing the ICF, not be breastfeeding and be willing to use a highly effective method of contraception as described below from enrollment to at least 6 months after the last dose of systemic trial treatment; b) Non-sterile males who are sexually active with WOCBP must be willing to use barrier methods such as a condom for effective contraception and refrain from sperm donation from enrollment to at least 6 months after the last dose of systemic trial treatment

Ki nem vehet részt

• Current or prior participation in another interventional trial that could interact with this trial
• Non-compliance, for reasons including, but not limited to, the following: Drug dependency or substance abuse that would interfere with cooperation with requirements of the trial; Refusal of blood products during treatment; Any similar circumstances that appear to make compliance with any trial procedures impossible
• Prior cHL-directed treatment
• Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
• Prior or concurrent disease precluding protocol treatment
• Live vaccine or live-attenuated vaccine within 30 days before signing the ICF. Administration of killed vaccines is allowed
• History of documented allergic reactions or acute hypersensitivity reaction to antibody treatment
• Known hypersensitivity or allergy to any of the excipients in the pembrolizumab formulation
• Target disease exceptions: Knwon central nervous system lymphoma, subjects with nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
• Abnormal laboratory test findings: a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. Patients who receive an antiviral treatment and have no detectable hepatitis B virus (HBV)-DNA or hepatitis C virus (HCV)-RNA can be included in the trial; b) Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) < 30 mL/min measured directly or calculated using the CKD-EPI formula; c) Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN. d) Total bilirubin > 1.5 x ULN unless the elevation is due to Gilbert’s syndrome h) International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) > 1.5 x ULN
• Lack of accountability and inability to appreciate the nature, meaning, and consequences of the trial and to formulate their own wishes correspondingly
• Relationship of dependence or employer-employee relationship to the sponsor or the investigator
• Committal to an institution on judicial or official order
• Pregnancy or breastfeeding