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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT00201669
Eligibility Criteria:
Inclusion Criteria:
* Must have histologically confirmed aggressive NHL
* B-cell NHL must be relapsed/ refractory
* T-cell \& NK-cell and transformed lymphoma eligible at DX
* Patients with B-cell NHL (ie, diffuse large B-cell lymphoma, mantle cell lymphoma, and Burkitt's lymphoma) must have relapsed or refractory disease after at least 1 prior therapy.
* Patients previously treated with radioimmunotherapy (ie, ibritumomab tiuxetan \[Zevalin\] or tositumomab \[Bexxar\]) or prior stem cell transplant (SCT) are eligible.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Life expectancy of at least 12 weeks.
* Laboratory values obtained ≤ 7 days prior to registration:
* Absolute neutrophil count (ANC) ≥ 1500/mm3
* Platelets ≥ 100,000/mm3
* Total bilirubin ≤ upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 × ULN
* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 × ULN
* Serum creatinine ≤ ULN
Exclusion Criteria:
* No prior treatment with clofarabine.
* Full recovery from all acute toxicities associated with prior chemotherapy, radiotherapy, or immunotherapy.- Patients with active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy) are not eligible.
* Cardiac function (i.e. left ventricular ejection fraction) ≥ 50% on pretreatment radionuclide ventriculography (RVG) or echocardiogram.
* Women that are pregnant or breastfeeding.
* Known HIV disease.
* No CNS lymphoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00201669
Study Brief:
Protocol Section:
NCT00201669