Do Serum Alemtuzumab Concentrations Predict Donor T Cell Chimerism After Non-Myeloablative Matched Sibling Donor Stem Cell Transplantation in Sickle Cell Disease Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Objectives: To investigate whether serum alemtuzumab concentrations are predictive of the robustness of engraftment in SCD patients undergoing a matched sibling donor transplantation with alemtuzumab/TBI conditioning resulting in mixed chimerism. Study design: Prospective observational laboratory study. Serum alemtuzumab concentration will be measured at various time points before and after stem cell infusion (days -3, 0, +7, +14, +28, +60). Study population: Adult SCD patients that are planned for a matched sibling donor transplantation with alemtuzumab/TBI conditioning at the Amsterdam UMC. Main study parameters/endpoints: The correlation between serum alemtuzumab concentration and levels of donor chimerism. Secondary endpoints: correlation between serum alemtuzumab levels and patients with and without successful engraftment. Correlation of serum alemtuzumab levels and the dosing of alemtuzumab in mg/kg, number of patient lymphocyte count and total number of infused enucleated donor-derived cells.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• Age 16 years and older

• High performance liquid chromatography (HPLC) confirmed diagnoses of SCD (all genotypes)

• Planned for a non-myeloablative matched sibling donor SCT with alemtuzumab/TBI at the Amsterdam UMC

• Willing and able to provide written informed consent

Locations
Other Locations
Netherlands
Amsterdam Medical Centre
RECRUITING
Amsterdam
Contact Information
Primary
Erfan Nur, MD, PhD
e.nur@amsterdamumc.nl
0031-20 - 4442604
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2025-11
Participants
Target number of participants: 20
Treatments
Sickle cell disease patients aged 16 years and older with an available matched sibling donor.
Alemtuzumab 1mg/kg/TBI 3Gy conditioning
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Leiden University Medical Center

This content was sourced from clinicaltrials.gov

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