Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology
This is a single-arm, open-label study of Iodine 131 Anti B1 Antibody for the treatment of
1st or 2nd relapsed indolent B cell lymphomas or B cell lymphomas that have transformed to a
more aggressive histology. The primary endpoint of the study is to determine the response
rate. Secondary endpoints of the study is to determine the duration of response, time to
progression, time-to-treatment failure, safety, and survival.
Forty patients will receive therapy on this study at the 2 clinical sites. Patients will
undergo 2 phases of the study. In the first phase, termed the "dosimetric dose", patients
will receive an infusion of unlabeled Anti B1 Antibody (450 mg) over 70 minutes (including a
10 minute flush) immediately followed by a 30 minute infusion (including a 10 minute flush)
of Anti B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of Iodine 131. Whole
body gamma camera scans will be obtained on 1) Day 0; 2) Day 2, 3, or 4; and 3) Day 6 or 7
following the dosimetric dose. Using the dosimetric data from the 3 imaging timepoints, a
patient-specific dose of Iodine 131 Anti B1 Antibody to deliver the desired total body dose
of radiotherapy will be calculated. In the second phase, termed the "radioimmunotherapeutic
dose", patients will receive a 70 minute infusion (including a 10 minute flush) of unlabeled
Anti B1 Antibody (450 mg) immediately followed by a 30 minute infusion (including a 10
minute flush) of 35 mg Anti B1 Antibody labeled with the patient-specific dose of Iodine 131
to deliver a whole body dose of 75 cGy to patients with no hematologic risk factors.
Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and
patients who are obese will be dosed based upon 137% of their lean body mass (see Appendix
A). Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's
solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion
of the Iodine 131 Anti B1 Antibody and continuing for 14 days following the last infusion of
Iodine 131 Anti B1 Antibody (i.e., therapeutic dose).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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