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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00005950
Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma
* Indolent B-cell lymphoma will include Waldenström's macroglobulinemia, lymphoplasmacytoid lymphoma small lymphocytic lymphoma, marginal zone lymphoma, and follicular small cleaved-cell or mixed cell lymphoma; patients with prior or concurrent evidence of transformation to large cell lymphoma or with follicular large cell lymphoma are ineligible
* Peripheral T-cell lymphoma will include all entities described in the REAL classification; patients with B-cell ALCL are ineligible; patients with cutaneous T-cell lymphoma and all its variants and/or histologic transformation of cutaneous T-cell lymphoma are not eligible for this protocol, because they will be instead eligible for a separate protocol
* Relapsed peripheral T-cell lymphomas include all those achieving and maintaining a complete or partial response during initial therapy; refractory includes those achieving all other responses during initial therapy; since the response rate of indolent B-cell lymphomas to up-front therapy exceeds 90% this distinction is not meaningful there
* No more than 2 prior chemotherapy and one prior immunotherapy regimens; if chemoimmunotherapy was used, the limit will be 3 prior regimens
* Performance status =\< 2 Zubrod
* Staging work-up within 3 weeks and bidimensionally measurable disease
* No anti-cancer treatment within the past three weeks
* ANC \>= 1,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma
* Platelets \>= 100,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma
* Bilirubin =\< 1.5 x normal
* SGPT =\< 2.5 x normal values
* Estimated endogenous creatinine clearance \> 50 ml/min
* HIV negative; the patients are excluded because the expected opportunistic infections will render study toxicity difficult to interpret; in addition the possible effects of 506U78 on CD4 cells may be dangerous to these patients; furthermore, indolent B-cell lymphomas and aggressive peripheral T-cell lymphomas are extremely rare in the setting of HIV infection
* No active CNS disease
* No other malignancy within the last 5 years, except basal cell carcinoma of the skin or in-situ cervical carcinoma treated with curative intent
* Females must not be pregnant or breast feeding and must be practicing adequate contraception; this is because 506U78 may be harmful to the developing fetus and nursing newborn or infant
* No preexisting sensory or motor neuropathy of grade ≥ 2, no history of seizures
* No prior stem cell or bone marrow transplantation; no prior 506U78
* All patients, including women or members of a minority that fulfill criteria for study entry will be eligible for treatment; no one fulfilling all these criteria for entry will be denied treatment solely on the basis of sex or minority status
* Patients with medical, psychiatric, or social conditions that make compliance with treatment or follow-up unlikely are not eligible
* No history of symptomatic cardiac dysfunction or pericardial effusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00005950
Study Brief:
Protocol Section:
NCT00005950