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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00822120
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
* Previously untreated stage III or IV disease
* No nodular lymphocyte predominant disease
* Bidimensionally measurable disease
* Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
* Tissue obtained from core biopsies allowed
* No tissue obtained from needle aspirations or cytologies
* Must have known HIV status
* No multi-drug resistant HIV infection, CD4 counts \< 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients
* HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count \> 250/μL at any time within 8 months prior to HL diagnosis allowed
* Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
* Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days
* Combined PET/CT scans required
* No older "stand-alone" FDG-PET scans
* No low-resolution "localization" CT scans as part of a combined PET/CT scans
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin, albumin, white blood cell count (WBC), and lymphocytes measured within the past 28 days
* Serum estradiol (women only), testosterone (men only), follicle stimulating hormone (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60 days prior to registration
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* No significant cardiac abnormalities as assessed by multiple gated acquisition scan (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms
* Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
* Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
* Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
* No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (DLCO) \> 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
* No requirement for continuous supplemental oxygen therapy
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
* No prior solid organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00822120
Study Brief:
Protocol Section:
NCT00822120