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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00290433
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+ T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also excluded. For patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.
2. Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).
3. Serum bilirubin \</= 1.5 mg/dl and serum creatinine \</= 2.0 mg/dl unless due to lymphoma; Absolute neutrophil count (ANC) \>/= 1000 mm\^3 and platelets \>/= 100,000 mm\^3 unless due to lymphoma.
4. Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA) or echocardiogram.
5. Ages 18 and older.
6. Patients must be willing to receive transfusions of blood products.
Exclusion Criteria:
1. Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.
2. Pregnancy
3. HIV positive serology
4. Central nervous system (CNS) involvement
5. Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator
6. Concurrent or previous malignancy whose prognosis is poor (\<90% probability of survival at 5 years)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00290433
Study Brief:
Protocol Section:
NCT00290433