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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT00816959
Eligibility Criteria:
Inclusion Criteria:
* Must sign the informed consent form
* Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology.
* Patients of both gender
* Patients between ages of 16 and 65 years
* Patients must have bi-dimensionally measurable disease
* Patients with adequate bone marrow reserve (ANC\>1500/mm3 ; Platelets\> 50,000/ mm3)
* LVEF \>/= 50% as measured by echocardiogram
* Serum creatinine \< 2mg/dl
* Serum bilirubin \< 2mg/dl; AST or ALT \< 2x ULN
* International Prognostic Score of \>2 (Patients must have \> 2 of the following risk features: Male \>/= 45 years of age, Stage IV, Albumin \<4, WBC \>/= 15, Lymphocytes \< 8% or \< 600, Hb \< 10.5)
Exclusion Criteria:
* Classic Hodgkin's disease
* Known HIV infection
* Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method.
* Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma
* Acute infection requiring treatment with intravenous therapy
* Presence of CNS lymphoma
* Concomitant malignancies or previous malignancies within the last 5 years
* Active Hepatitis B or C infection
* Uncontrolled active infection
* Concurrent prednisone or systemic steroid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT00816959
Study Brief:
Protocol Section:
NCT00816959