Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Follicular Lymphoma · 1 trial · 1 indication
Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.
Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.
The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.
Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.
Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.
| Arm | Type | Description |
|---|---|---|
| tositumomab and iodine I 131 tositumomab | EXPERIMENTAL | Subjects participating in this study will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I-131 tositumomab, immediately following an infusion of 450 mg of unlabeled tositumomab. Using the dosimetric data from three of the six imaging time points and the subject's weight, a patient-specific activity (mCi) of Iodine I-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). All subjects will then receive an infusion of unlabeled tositumomab (450 mg) immediately followed by an infusion of the subject specific dose of tellurium-derived Iodine I-131 tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. |
| Name | Type | Description |
|---|---|---|
| Follicular Lymphoma | BIOLOGICAL | For subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's |
Inclusion criteria 1. At least 18 years of age 2. A histologically confirmed diagnosis of the following: Follicular lymphoma, Grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (World Health Organization/Revised European-American Ly...
Follicular lymphoma is a type of non-Hodgkin lymphoma, a cancer of the lymphatic system. It is the subject of a Phase 1 clinical trial conducted by GSK plc (ticker: GSK). The trial evaluated a monoclonal antibody in patients with previously untreated or relapsed follicular or transformed non-Hodgkin's lymphoma.
GSK plc, which trades under the ticker GSK, is the developer associated with the follicular lymphoma program. The company sponsored a Phase 1 trial in this indication.
Follicular lymphoma is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed trial enrolled 15 patients and was uncontrolled, non-randomized, and not double-blinded.
Follicular lymphoma has been studied in one completed Phase 1 trial, NCT00315731. The trial was titled 'A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma.' It enrolled 15 patients aged 18 years and older.
Yes, the follicular lymphoma program is biomarker-selected. The completed Phase 1 trial NCT00315731 used a biomarker-based selection approach. The trial enrolled 15 patients and was conducted in patients with previously untreated or relapsed follicular or transformed non-Hodgkin's lymphoma.