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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT00041327
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL)
* Previously treated ATLL allowed
* CD3-positive
* Documented HTLV-1 infection by serologic assay (ELISA, Western blot)
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 50-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3\*
* Platelet count greater than 75,000/mm\^3\* NOTE: \*Unless cytopenia is secondary to ATLL
Hepatic:
* Transaminase less than 7 times upper limit of normal
* Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir)
Renal:
* Creatinine less than 2.0 mg/dL (unless due to lymphoma)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study completion
* No active opportunistic infection requiring acute therapy
* No untreated thyroid disease
* No autoimmune disease
* No uncontrolled significant psychiatric disease
* No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 24 hours since prior hematologic growth factors
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* Concurrent chronic therapy with potentially myelosuppressive agents allowed
* Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00041327
Study Brief:
Protocol Section:
NCT00041327