Do Serum Alemtuzumab Concentrations Predict Donor T Cell Chimerism after Non-Myeloablative Matched Sibling Donor Stem Cell Transplantation in Sickle Cell Disease Patients? (PREDICT study)

Recruiting

• Conditions: hemoglobinopathy; Sickle cell disease; 10018902

• Registration Number: NL-OMON51521
• Lead Sponsor: Hematologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

o Age 16 years and older
o High performance liquid chromatography (HPLC) confirmed diagnoses of SCD (all
genotypes)
o Planned for a non-myeloablative MSD transplantation with alemtuzumab/TBI at
the Amsterdam UMC
o Willing and able to provide written informed consent

Exclusion Criteria

- No specific exclusion criteria

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The correlation between serum alemtuzumab concentration and levels of donor<br /><br>chimerism. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The correlation between serum alemtuzumab levels and patients with and without<br /><br>successful engraftment. Correlation of serum alemtuzumab levels and the dosing<br /><br>of alemtuzumab in mg/kg, number of patient lymphocytes and total number of<br /><br>infused enucleated donor-derived cells.</p><br>