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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00654732
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV
* International Prognostic Score of \> 2 (patient must have \> 2 of the following risk features: Male, \>= 45 years of age, stage IV, albumin \< 4, white blood cell count \[WBC\] \>= 15, lymphocytes \< 8% or \< 600, hemoglobin \[Hgb\] \< 10.5)
* Must sign a consent form
* Absolute neutrophil count (ANC) \>= 1,500/microL
* Platelet \> 100,000/microL
* Left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition (MUGA) scan or echocardiogram
* Serum creatinine \< 2 mg/dl
* Serum bilirubin \< 2 mg/dl
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN)
* Bi-dimensionally measurable disease
Exclusion Criteria:
* Lymphocyte predominant Hodgkin's lymphoma
* Known human immunodeficiency virus (HIV) infection
* Pregnant women and women of child bearing age who are not practicing adequate contraception
* Prior chemotherapy or radiation therapy
* Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma
* Active infection requiring treatment with intravenous therapy
* Presence of central nervous system (CNS) lymphoma
* Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix)
* Active hepatitis B or C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT00654732
Study Brief:
Protocol Section:
NCT00654732