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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00026351
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed low-grade non-Hodgkin's lymphoma
* REAL classification:
* B-cell chronic lymphocytic leukemia
* Prolymphocytic leukemia
* Small lymphocytic lymphoma
* Follicular center lymphoma (grade I, II, or III)
* Extranodal marginal zone B-cell lymphoma Malt type
* International Working Group classification:
* Small lymphocytic/chronic lymphocytic leukemia (CLL)
* CLL with lymph node involvement allowed
* Small lymphocytic plasmacytoid
* Follicular small cleaved cell
* Follicular mixed small and large cell
* Follicular predominantly large cell
* Measurable disease
* Lymph node more than 1 cm in longest transverse diameter NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 6 months
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST no greater than 5 times upper limit of normal
Renal:
* Creatinine less than 2.0 mg/dL
* BUN normal
* Urinalysis normal
Cardiovascular:
* LVEF normal in patients with history of stable heart disease for at least 2 years
Other:
* HIV negative
* No thyroid disease with thyroid function that cannot be maintained in the normal range
* No other prior malignancy unless progression free for more than 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior rituximab, Y2B8, or iodine I 131 tositumomab allowed provided at least 6 months have elapsed and patient has had clear disease progression
* No other concurrent immunotherapy
Chemotherapy:
* No more than 6 prior chemotherapy drugs
* No more than 3 prior treatments with pentostatin
* At least 3 weeks since prior chemotherapy
* No prior cumulative lifetime dose of more than 480 mg/m2 of doxorubicin or an equivalent dose of any anthracycline
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No concurrent radiotherapy to an indicator lesion
Surgery:
* Not specified
Other:
* No other concurrent investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00026351
Study Brief:
Protocol Section:
NCT00026351