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 @ 1:31 PM
Ignite Modification Date:
2025-12-24 @ 1:31 PM
NCT ID:
NCT00049595
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed Hodgkin's lymphoma
* No lymphocyte predominant, nodular type (nodular paragranuloma)
* Clinical stage III or IV disease
* At least 1 bidimensionally measurable target lesion or extranodal lesion
* International Prognostic Score of at least 3
PATIENT CHARACTERISTICS:
Age
* 16 to 60
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* No prior uncontrolled hepatitis B viral infection
* Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)
Renal
* Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)
Cardiovascular
* No severe cardiac disease that would limit normal life expectancy or preclude study
* LVEF at least 50%
Pulmonary
* No severe pulmonary disease that would limit normal life expectancy or preclude study
* Respiratory function at least 30%
Other
* HIV negative
* HTLV1 negative
* No severe active infection
* No severe neurological or metabolic disease that would limit normal life expectancy or preclude study
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No prior therapy for Hodgkin's lymphoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00049595
Study Brief:
Protocol Section:
NCT00049595