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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00093704
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Epstein Barr virus-positive lymphoma, including the following subtypes:
* Post-transplantation lymphoma
* Burkitt's lymphoma
* Hodgkin's lymphoma
* T-/NK-cell lymphoma
* Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
* Bidimensionally measurable disease by CT scan
* At least 1 lesion ≥ 1.5 cm in the greatest diameter
* Age 18 and over
* ECOG 0-2 OR
* Karnofsky 50-100%
* Life expectancy More than 3 months
* Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3 (no growth factor support within the past 4 weeks)
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 50,000/mm\^3 (no platelet transfusions within the past 4 weeks)
* Hepatic
* Bilirubin ≤ 2.0 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement)
* No active hepatitis B or C
* Renal
* Creatinine clearance ≥ 60 mL/min
* Sodium \> 130 mmol/L
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* At least 4 weeks since prior immunotherapy
* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior radiotherapy
* More than 4 weeks since prior major surgery unless fully recovered
* Recovered from all prior therapy
* At least 4 weeks since prior investigational agents
Exclusion Criteria:
* primary or secondary CNS lymphoma or HIV-related lymphoma
* known brain metastases
* myocardial infarction within the past 6 months
* acute ischemia or new conduction system abnormalities by electrocardiogram
* symptomatic congestive heart failure
* unstable angina pectoris
* cardiac arrhythmia
* hospitalized
* pregnant or nursing
* other uncontrolled illness
* ongoing or active systemic infection
* psychiatric illness or social situation that would preclude study compliance
* history of allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
* sensitivity to boron, mannitol, bortezomib, or ganciclovir
* concurrent corticosteroids (≥ 10 mg of prednisone or equivalent)
* concurrent radiotherapy
* other concurrent anticancer therapy
* other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00093704
Study Brief:
Protocol Section:
NCT00093704