Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody · 1 trial · 1 indication
Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =\<2 centimeters (cm) in diameter by radiographic evaluation or =\<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.
Confirmed PR is defined as a \>=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.
Response duration is defined as the time from the first documented response until disease progression.
Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be \>2 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Response duration is defined as the time from the first documented response until disease progression.
Response duration is defined as the time from the first documented response until progressive disease.
Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.
Duration of response is defined as the time from the first documented response to disease progression.
CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
Duration of response is defined as the time from the first documented response to disease progression.
Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.
Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Overall survival is defined as the time from the treatment start date to the date of death from any cause.
| Arm | Type | Description |
|---|---|---|
| open-label, single arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) | BIOLOGICAL | Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose. |
Inclusion Criteria * Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation. * Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tiss...