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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00109928
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of peripheral T-cell non-Hodgkin's lymphoma
* Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a non-platinum based chemotherapy (e.g., CHOP)
* Bulky stage II or stage III or IV disease
* The following histologies are not eligible:
* T-cell prolymphocytic leukemia
* T-cell large granular lymphocytic leukemia
* Any NK-cell leukemia
* Adult T-cell leukemia/lymphoma
* Mycosis fungoides/Sézary syndrome
* Lymphomatoid papulosis
* Nasal-type extranodal NK/T-cell lymphoma
* Enteropathy-type T-cell lymphoma
* Hepatosplenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Angioimmunoblastic T-cell lymphoma
* Primary cutaneous anaplastic large cell lymphoma (ALCL)
* ALCL with CD30, ALK, and EMA expression
* ALCL morphology that fails to express ALK or EMA allowed provided T-cell lineage is confirmed by immunotyping or genetic testing
* Bidimensionally measurable disease
* Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available
* Needle aspiration or cytology is not considered adequate samples
* No clinical evidence of Central nervous system (CNS) involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal
Renal
* Creatinine clearance ≥ 30 mL/min
Cardiovascular
* No history of congestive heart failure
* No history of myocardial infarction
* No history of unstable angina
* No history of asymptomatic arrhythmias
* Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with questionable cardiac history)
* No other history of impaired cardiac status
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* Mild clinical hearing loss allowed provided patient is willing to accept the potential for worsening of hearing loss
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis within the past 28 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic therapy
* No concurrent routine use of bone marrow colony-stimulating factors
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for this cancer
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No prior cytotoxic therapy for this cancer
* Concurrent enrollment in SWOG-8819 or SWOG-8947 allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00109928
Study Brief:
Protocol Section:
NCT00109928