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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT05243693
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of classical Hodgkin's lymphoma. CD30 has to be positive
2. Refractory to the first-line treatment or relapse after the first-line treatment (radiologically confirmed)
* Deauville score 5 as a result of the restaging PET-CT after 2 to 3 cycles of ABVD treatment
* Deauville score 4 to 5 even after the completion of ABVD treatment or radiotherapy and are not candidates for ISRT (involved site radiation therapy)
* Radiologically confirmed relapsed after achieving CR
3. At least one measurable lesion(s)
* nodal lesion longest transverse diameter (LDi) ≥ 1.5 cm
* extranodal lesion LDi ≥ 1.0 cm)
4. Age 19 to 70 years
5. ECOG PS 0 - 2
6. Appropriate organ functions to tolerate the protocol treatment and ASCT Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L Platelets ≥ 75 x 10\^9/L Hemoglobin ≥ 8.0 g/dL Serum Creatinine ≤ 1.5 x upper limit normal (ULN) Serum Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3 x ULN Corrected diffusing capacity for carbon monoxide (DLCO) ≥50 percent
7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
8. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
9. Written informed consent
Exclusion Criteria:
1. Non-Hodgkin's lymphoma or nodular lymphocyte predominant Hodgkin's lymphoma
2. 2 or more prior lines of treatment (Palliative radiotherapy or high-dose steroid therapy for symptom control are allowed)
3. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
4. Confirmed CNS involvement and/or symptomatic neurologic disease compromising normal activities of daily living or requiring medications
5. Patients who cannot tolerate high-dose therapy followed by ASCT described in the inclusion criteria 6.
6. Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders. For example, i. severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and/or O2 saturation that is 90% or less at rest on room air ii. any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study iii. nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication iv. creatinine clearance \< 30 mL/min
7. Known history of any of the following cardiovascular conditions i. Myocardial infarction within 2 years of enrollment ii. New York Heart Association (NYHA) Class III or IV heart failure iii. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities iv. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \<50%
8. Synchronous or metachronous malignant tumor other than HL within 5 years (except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, carcinoma in situ of the uterine cervix, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).
9. Hypersensitivity to the investigational products.
10. Peripheral neuropathy ≥ Grade 2
11. Pregnant or nursing women
12. Human immunodeficiency virus (HIV)-positive
13. Active hepatitis B or hepatitis C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT05243693
Study Brief:
Protocol Section:
NCT05243693