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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00392834
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed Burkitt's lymphoma (BL) or new WHO 2009 criteria B-cell lymphoma unclassified (with features intermediated between difuse large B-cell lymphoma and BL)
* Any stage disease
* Newly diagnosed disease
* Meets 1 of the following criteria for disease risk:
* Low-risk disease, defined by 1 of the following:
* Stage I with a single focus of disease \< 10 cm AND normal lactate dehydrogenase (LDH) level
* Totally resected intra-abdominal disease only AND normal LDH post surgery
* High-risk disease, defined as not meeting criteria for low-risk disease
* Measurable or nonmeasurable disease
* HIV-positive confirmed by enzyme-linked immunosorbent assay and Western blot OR by measurable HIV viral load
* No visceral Kaposi's sarcoma
PATIENT CHARACTERISTICS:
* Karnofsky performance status 40-100%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* LVEF ≥ 50% by MUGA or echocardiogram
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³ (unless related to lymphoma)\*
* Direct bilirubin ≤ 2.0 mg/dL OR total bilirubin ≤ 3.5 mg/dL AND direct bilirubin normal (if elevated bilirubin secondary to antiretroviral therapy)
* AST and ALT ≤ 3 times upper limit of normal
* No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or cutaneous Kaposi's sarcoma
* No other medical illness unrelated to non-Hodgkin's lymphoma, including any of the following:
* Uncontrolled infection (including opportunistic infection)
* Chronic renal insufficiency
* Myocardial infarction within the past 6 months
* Unstable angina
* Cardiac arrhythmias other than chronic atrial fibrillation
* Patients with active hepatitis B infection are eligible provided they receive concurrent dual antiviral therapy NOTE: \*Patients with bone marrow involvement are eligible irrespective of blood count
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior therapy for this disease except for 1 of the following :
* Seven consecutive days of steroids alone or in combination with a non-CHOP regimen necessary for patient stabilization (e.g., cyclophosphamide and steroids steroids for normalization of disease-related hyperbilirubinemia)
* One course of CHOP or fractionated CHOP (e.g. CODOX) with or without rituximab
* No epoetin alfa or filgrastim (G-CSF) within 24 hours of study chemotherapy
* No concurrent zidovudine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00392834
Study Brief:
Protocol Section:
NCT00392834