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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04843267
Eligibility Criteria:
Inclusion Criteria:
1. Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology;
2. Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)
3. Patients not suitable for receiving radiotherapy subsequently
4. Patients with at least one assessable lesion (according to Lugano 2014 standard);
5. Age 18 or above (including 18), no gender requirement;
6. ECOG PS score of 0-1 points;
7. Expected survival time ≥ 3 months;
8. Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST \<1.5×ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy \<2000 IU/ml and ALT\<2×ULN; renal function: creatinine \<1.5×ULN and creatinine clearance rate ≥50ml/min;
9. With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy;
10. Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment;
11. Voluntarily signing an informed consent form before trial screening.
Exclusion Criteria:
1. Nodular lymphocyte predominant HL;
2. Patients received any form of anti-tumor therapy in the past;
3. Patients planning to receive radiotherapy or autologous stem cell transplantation;
4. With involvement of central nervous system (meninges or brain parenchyma);
5. Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures;
6. Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation;
7. Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment;
8. Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment,
9. Patients with known active interstitial pneumonia;
10. Abnormal liver function (total bilirubin\>1.5×ULN, ALT/AST\>2.5×ULN or ALT/AST\>5×ULN for patients with liver invasion), abnormal renal function (serum creatinine\>1.5×ULN), abnormal electrolyte metabolism;
11. Peripheral neuropathy ≥ Grade 2;
12. Patients with a history of prolonged QT interval which is of clinical significance (male\> 450ms, female\> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug therapy;
13. Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;
14. Mentally disturbed/patients unable to give informed consent;
15. Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse;
16. Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04843267
Study Brief:
Protocol Section:
NCT04843267