2024-520138-31-00尚未招募2 期
PREFer: Phase II trial of anti-PD-1 antibody treatment and radiotherapy in early-stage favorable classic Hodgkin lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 35
- 主要终点
- Progression-free survival (PFS) at 1 year
研究概览
简要总结
The primary objective is to estimate the efficacy of the experimental treatment with the anti-PD-1 antibody pembrolizumab followed by consolidation radiotherapy (RT) in early-stage favorable classic Hodgkin lymphoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •Target disease exceptions: Knwon central nervous system lymphoma, subjects with nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
- •Current or prior participation in another interventional trial that could interact with this trial.
- •Lack of accountability and inability to appreciate the nature, meaning, and consequences of the trial and to formulate their own wishes correspondingly.
- •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
- •Relationship of dependence or employer-employee relationship to the sponsor or the investigator.
- •Committal to an institution on judicial or official order.
- •Prior cHL-directed treatment
- •Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
- •Prior or concurrent disease precluding protocol treatment
- •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
- •Live vaccine or live-attenuated vaccine within 30 days before signing the ICF. Administration of killed vaccines is allowed.
- •Pregnancy or breastfeeding.
- •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.
结局指标
主要结局
Progression-free survival (PFS) at 1 year
Progression-free survival (PFS) at 1 year
次要结局
- Rate and types of HL-directed treatment administered in addition to trial treatment
- Event-free survival (EFS) at 1 year and at 2 years
- Remission status after pembrolizumab therapy and after consolidation Radiotherapy
- Progression-free survival (PFS) at 2 years
- Overall survival (OS) at 1 year and at 2 years
- Adverse events during and after anti-PD-1 therapy
- Patient-reported outcomes at baseline, during treatment and during follow-up
- Rate of early discontinuation of trial treatment
研究者
Dennis Eichenauer
Scientific
University Of Cologne
研究点 (35)
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