Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 11, 2023

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2028

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. A 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

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER