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)

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) - Do Alemtuzumab Levels Predict T cell chimerism after SCT for SCD?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51521

Enrollment

Registered

2022-07-04

Start date

2022-07-15

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemoglobinopathy Sickle cell disease

Interventions

None listed

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: - No specific exclusion criteria

Design outcomes

Primary

Measure	Time frame
The correlation between serum alemtuzumab concentration and levels of donor chimerism.	—

Secondary

Measure	Time frame
The 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 lymphocytes and total number of infused enucleated donor-derived cells.	—

Countries

Netherlands

Outcome results