Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow Involvement

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

May 28, 1999

Primary Completion Date

June 7, 2012

Study Completion Date

June 7, 2012

Conditions
Lymphoma, Non-Hodgkin
Interventions
BIOLOGICAL

Iodine-131 Anti-B1 Antibody

"Dosimetric Dose: 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes.~Therapeutic Dose: 7-14 days after dosimetric dose, 450 mg Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY