Phase II Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma.
This is a phase II, open-label, multicenter study of the efficacy and safety sequential
administration of cycolophosphamide, vacristine, and prednisone (CVP) x6 cycles followed by
tositumomab and iodine I 131 tositumomab for previously untreated subjects with low-grade
Non-Hodgkin's Lymphoma (NHL). CVP will be repeated every 21 days for a total of six cycles.
tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day
of the sixth cycle of CVP. Subjects will undergo two dosing phase for the tositumomab and
iodine I 131 tositumomab therapy. In the first phase, "dosimetric dose", patients will
receive an infusion of unlabeled Anti-B1 Antibody (450mg) over 60 minutes followed by a 30
minute infusion (including a 10-minutes flush) of Anti-B1 (35mg) containing 5mCi of
Iodine-131. 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. Using the dosimetric data from three time points, a
patient-specific dose of Iodine-131 will be calculated to deliver the desired total body
dose of radiotherapy. In the second phase, termed the "therapeutic dose", patients will
receive 60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute
infusion (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with the subjects
-specific dose of Iodine-131 calculate to deliver a 75cGy total body radiation dose.
Subjects who have platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy; obese
patients will be dosed base upon 137% of their lean body mass. Subjects will be treated with
saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets
starting at least 24 hours prior to the first infusion of the tositumomab and iodine I 131
tositumomab (i.e., the dosimetric dose) and continuing for 14 days following the least
infusion of tositumomab and iodine I 131 tositumomab (i.e., the therapeutic dose).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator
Par. with 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), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, 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).
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
GSK Clinical Trials
United States: Food and Drug Administration