Status:
COMPLETED
Precision Dosing of Alemtuzumab
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Allogeneic Hematopoietic Cell Transplantation
Eligibility:
All Genders
6-30 years
Phase:
NA
Brief Summary
The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with non-malignant diseases. Th...
Detailed Description
The hypothesis is that the model-informed dosing regimen will prospectively allow the precision dosing of alemtuzumab to target Day 0 levels to fall between 0.15-0.6ug/mL in greater than 80% of patien...
Eligibility Criteria
Inclusion
- Patients who are undergoing RIC HCT with alemtuzumab, fludarabine, and melphalan at CCHMC for treatment of a non-malignant disease.
- Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
- For the first 7 patients, patients must have a 10/10 HLA matched related or unrelated stem cell donor, or be receiving a CD34+ selected stem cell product. After the first 7 patients, any donor match may be allowed after data review by the PI and medical monitor.
Exclusion
- Patients with a history of anaphylaxis to alemtuzumab.
- Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
- Life expectancy less than 2 weeks.
- Patients receiving dialysis.
- Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
- It is not medically advisable to obtain the specimens necessary for this study.
- Not able to tolerate subcutaneous dosing (patients with severe skin conditions such as epidermolysis bullosa).
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03302754
Start Date
October 5 2017
End Date
March 10 2019
Last Update
October 4 2019
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229