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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00475332
Eligibility Criteria:
Inclusion Criteria
* Relapsed Stage I-IV (no evidence of bone marrow involvement) Follicular Non- Hodgkin's Lymphoma (NHF). Patients must have received at least 1 prior therapeutic regimen of chemotherapy or Rituximab and demonstrated progression as demonstrated by biopsy.
* One or more of the relapsed sites must be 5 cm or greater in dimension as assessed on two dimensional imaging from CT or MRI scan.
* Biopsy at time of relapse confirming continued presence of CD 20 positive follicular lymphoma.
* No anti-cancer therapy for 3 weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, chemotherapy, or immunotherapy.
* An IRB-approved signed informed consent.
* Expected survival rate greater than 3 months.
* Prestudy performance status of 0 or 1 according to the World Health Organization (WHO) criteria
* Acceptable hematologic status within two weeks prior to patient registration, including:
* Absolute neutrophil count (ANC) (\[segmented neutrophils + bands\] x total white blood cells) greater than 1,500/mm\^3
* Platelet counts greater than 100,000/mm\^3
* Female patients who are not pregnant or lactating.
* Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however, abstinence is not an acceptable method).
* Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post-treatment toxicities observed.
Exclusion Criteria
* Patients with impaired bone marrow reserve, as indicated by one or more of the following:
* Prior myeloablative therapies with bone marrow transplantation (either autologous or allogeneic) or peripheral blood stem cell (PBSC) rescue.
* Platelet count \> 100,000 cells/mm\^3
* Hypocellular bone marrow
* Marked reduction in bone marrow precursors of one or more cell lines (granulocytic,megakaryocytic, erythroid).
* History of failed stem cell collection
* Presence of bone marrow involvement with follicular lymphoma (FL) \> 25% based on bone marrow biopsy done within 2 months of enrollment.
* Evidence of transformation from original FL to a more aggressive NHL histology.
* Prior radioimmunotherapy.
* All relapsed sites are \< 5 cm in dimension as assessed on two dimensional imaging from CT or MRI scan.
* Presence of CNS (central nervous system) involvement.
* Presence of primary Non-Hodgkin Lymphoma (NHL) of bone.
* Patients with HIV or AIDS-related lymphoma.
* Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL.
* Patients who have received prior external beam radiation therapy within three months of registration.
* Patients who have received G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte-macrophage colony stimulating factor) therapy within two weeks prior to treatment.
* Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
* Major surgery, other than diagnostic surgery, within four weeks.
* Presence of anti-murine antibody (HAMA) reactivity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00475332
Study Brief:
Protocol Section:
NCT00475332