Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02414568
Eligibility Criteria:
Inclusion Criteria:
* Patient with a first diagnosis of classical Hodgkin lymphoma according to the World Health Organization (WHO) criteria excluding nodular lymphocyte predominant subtype
* Age of 61 years or older
* No previous treatment for Hodgkin lymphoma
* Ann Arbor stages:
* II with mediastinum/thorax ≥0.33 or extranodal localization and with B symptoms
* Or III
* Or IV
* Baseline 18-FluoroDeoxyGlucose (FDG) PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate cardio-pulmonary function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%
* Adequate renal function with creatinine clearance ≥ 40 mL/mn (MDRD formula)
* For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) ≥ 17
* A minimum life expectancy of 3 months
* Negative Human Immunodeficiency Virus, Hepatitis B (HB) Virus (anti-HB c negativity) and Hepatitis C Virus serologies tests ≤ 30 days before inclusion (except after vaccination)
* Having previously signed a written informed consent
* The patient must be covered by a social security system, if applicable
* Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment.
Exclusion Criteria:
* Any other type of lymphoma including nodular lymphocyte predominant subtype
* Any history of treated Hodgkin lymphoma
* Contra-indication to any drug contained in the chemotherapy regimens
* Any serious active disease (according to the investigator's decision)
* Poor hepatic function (total bilirubin level \> 30 μmol/L or transaminases \> 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
* Poor bone marrow reserve as defined by leukocytes \< 2 G/L or platelets \< 100 G/L, unless related to bone marrow infiltration
* Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings:
1. their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
2. they had definitive curative therapy (i.e. prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
3. at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or \< 1 ng/mL if they did not undergo prostatectomy
* Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
* Adult under tutelage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
61 Years
Study:
NCT02414568
Study Brief:
Protocol Section:
NCT02414568