Actively Recruiting
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-07-17
60
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Alemtuzumab is an antibody that reduces the strength of the immune system that is given in preparation for allogeneic hematopoietic cell transplant (HCT). In this research study the investigators want to find out if they can adjust the dose of alemtuzumab used as part of allogeneic HCT to target the level of Day 0 (the planned day of graft infusion) to an optimal therapeutic window of 0.15-0.9 ug/mL.
CONDITIONS
Official Title
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing allogeneic HCT at CCHMC with an alemtuzumab-containing preparative regimen for non-malignant diseases
- For the first 7 patients, must have a 10/10 HLA matched related or unrelated stem cell donor, or receive a CD34+ selected stem cell product
- After the first 7 patients, any donor match may be allowed after data review by clinicians and the principal investigator
You will not qualify if you...
- History of anaphylaxis to alemtuzumab
- Previously received alemtuzumab and have not cleared it before starting preparative regimen
- Life expectancy less than 4 weeks
- Receiving dialysis or plasmapheresis at the start of conditioning regimen
- Failure to sign informed consent or inability to undergo consent process
- Medically unable to provide specimens needed for the study
- Unable to tolerate subcutaneous dosing due to severe skin conditions
- Diagnosis of cancer
- Clinical condition preventing successful pharmacokinetic modeling, such as active flaring of hemophagocytic lymphohistiocytosis
- Presence of substances interfering with accurate alemtuzumab measurement before dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
C
Caitlin Cottrell
CONTACT
R
Richard Cooper
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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