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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01578967
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated stage I or II non-bulky Hodgkin lymphoma
* No mediastinal mass \>0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B)
* No adenopathy ≥7.5 cm in its largest diameter
* Measurable disease as assessed by 2 dimensional measurement by CT (\>2cm or 1.5 cm if 0.5 cm slices are used, as in spiral CT scan)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Age ≥18 years and ≤60 years of age
* Life expectancy of at least 3 months
* Adequate bone marrow function (without transfusion support within one week of screening) as demonstrated by:
* Hemoglobin ≥ 8 g/dL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
* Platelet count ≥ 75,000/mm3
* Adequate hepatic and renal function as demonstrated by:
* Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
* Total serum bilirubin ≤1.5 x ULN
* Serum creatinine ≤ 2.0 mg/dL
* Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential
* Females of childbearing potential, and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin. Effective contraception is defined as any medically recommended method (or combination of methods) as per standard of care, including abstinence. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
* Signed an institutional review board (IRB)-approved informed consent document for this protocol
Prior to Day 1 of brentuximab vedotin, patients must again meet the following inclusion criteria:
* Adequate bone marrow function (without transfusion support within one week of D1 of brentuximab vedotin) as demonstrated by:
* Hemoglobin ≥ 8 g/dL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
* Platelet count ≥ 75,000/mm3
* Adequate hepatic and renal function as demonstrated by:
* Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
* Total serum bilirubin ≤1.5 x ULN
* Serum creatinine ≤ 2.0 mg/dL
* Achieved at least a partial response (PR) (and not progressed) after ABVD therapy
Exclusion Criteria:
* Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines.
* Bulky disease (defined as a mass measuring \> 7.5 cm or one-third the maximal diameter of the thoracic cavity)
* Known central nervous system (CNS) involvement
* Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
* Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C (testing is not necessary if patient does not have history of these diseases, and no risk factors for acquisition of these viruses)
* Cardiac disease with left ventricular ejection fraction of less than 45%
* Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
* Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
* Other active malignancies with the exception of:
* Non-melanoma skin cancer
* Cervical carcinoma in situ without evidence of disease
* Prostatic intraepithelial neoplasia without evidence of prostate cancer
* Pregnant or lactating women
Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below:
* Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01578967
Study Brief:
Protocol Section:
NCT01578967