BridgeMD
PREFer
EU CTIS ID: 2024-520138-31-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.