Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab
 (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or
 transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine
 I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain
 additional safety and efficacy information for this treatment regimen. Post study drug
 administration follow-ups will continue for up to ten years. These will include blood-work
 and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week
 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years
 from the dosimetric dose and then annually thereafter through year 10. Thyroid function will
 be monitored annually during Long-term follow-up.
Inclusion Criteria:

 -  Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL
 (tumor must be CD 20 positive).

 -  Prior treatment with at least one chemotherapy regimen and have relapsed or
 progressed, or failed to achieve an objective response on last chemotherapy regimen.

 -  Karnofsky performance status of at least 60% and anticipated survival of at least 3
 months.

 -  Absolute granulocyte of >/= 1,500/mm3.

 -  Platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic
 cytokines, or transfusion of blood products.

 -  Adequate renal function (i.e., <1.5x Upper Limit of Normal), and hepatic transaminases
 (AST <5 times ULN).

 -  Signed IRB/IEC-approved informed consent.

 Exclusion Criteria:

 -  Patients with a mean of >25% of the intratrabecular marrow space involved with
 lymphoma.

 -  Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or
 cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea
 compounds) or who exhibit persistent clinical evidence of toxicity.

 -  Patients who have undergone stem cell or bone marrow transplant, active obstructive
 hydronephrosis, active infection, New York Heart Association Class III or IV heart
 disease or other serious illness that would preclude evaluation.

 -  Known HIV infection.

 -  Pregnant or nursing patients.

 -  Patients with prior malignancy other than lymphoma, except for adequately-treated skin
 cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free
 for 5 years.

 -  Patients with progressive disease within 1 year of irradiation arising in a field that
 has been previously irradiated with more than 3500 cGy.

 -  Patients who received prior radioimmunotherapy, known brain or leptomeningeal
 metastases, HAMA positivity.

 -  Patients who are receiving either approved or non-approved (through another protocol)
 anti-cancer drugs or biologics.