Precision Dosing of Alemtuzumab

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 5, 2017

Primary Completion Date

March 10, 2019

Study Completion Date

March 10, 2019

Conditions
Allogeneic Hematopoietic Cell Transplantation
Interventions
DRUG

Alemtuzumab

Alemtuzumab (Campath®) is a recombinant DNA-derived humanized monoclonal antibody directed against CD52. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. Alemtuzumab is a sterile, clear, colorless, isotonic pH 6.8-7.4 solution for injection. Alemtuzumab is supplied in single-use clear glass ampules containing 30 mg of Alemtuzumab in 3 mL of solution. Single use vial of alemtuzumab contains 30 mg alemtuzumab, 8 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate.

Trial Locations (1)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT03302754 - Precision Dosing of Alemtuzumab | Biotech Hunter | Biotech Hunter