Precision Dosing of Alemtuzumab
Completed · Not applicable
Conditions studied: Allogeneic Hematopoietic Cell Transplantation
In brief
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. The investigators will measure the ability to use a population PK model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot study of 20 patients.
Key facts
- Study ID
- NCT03302754
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 12
- Starts
- 2017-10-05
- Expected to finish
- 2019-03-10
- Last updated by the study team
- 2019-10-04
Who can join
Age: 0 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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