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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT00238368
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
* Diffuse large B-cell lymphoma
* Mediastinal (thymic) B-cell lymphoma
* Grade 3 follicular lymphoma
* Anaplastic large cell lymphoma
* Peripheral T-cell lymphoma
* Must have adequate staging of disease by the following techniques:
* CT scan or MRI of affected sites
* Bone marrow biopsy (in cases where results influence the duration of chemotherapy only)
* Lumbar puncture (if clinically indicated)
* Stage I-IV disease
* Any International Prognostic Index risk category
* Radiographically measurable disease
* None of the following aggressive non-Hodgkin's subtypes are allowed:
* Mantle cell lymphoma
* Lymphoblastic lymphoma
* Burkitt's lymphoma
* Mycosis fungoides/Sezary's syndrome
* HTLV-1-associated T-cell leukemia/lymphoma
* Primary CNS lymphoma
* HIV-associated lymphoma
* Transformed lymphomas
* No prior diagnosis of another hematologic malignancy
* No known progressive disease during prior first-line chemotherapy
* No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-4 (0-2 for peripheral blood stem cell \[PBSC\] or bone marrow transplantation \[BMT\] patients)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3\*
* Platelet count ≥ 75,000/mm\^3 NOTE: \*PBSC or BMT patients only
Hepatic
* Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma\*
* No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only
Renal
* Creatinine ≤ 2.0 mg/dL\*
* No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only
Cardiovascular
* Ejection fraction ≥ 45% by echocardiogram or MUGA\*
* No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion
Pulmonary
* FEV\_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)\*
* No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
* No known HIV positivity OR HIV negative (for PBSC or BMT patients only)
* No serious illness that would preclude study participation
* No contraindication to autologous BMT
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No more than 3 prior courses of chemotherapy for lymphoma
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00238368
Study Brief:
Protocol Section:
NCT00238368