Evaluating Alemtuzumab Levels in Sickle Cell Disease Transplantation
Do Serum Alemtuzumab Concentrations Predict Donor T Cell Chimerism After Non-Myeloablative Matched Sibling Donor Stem Cell Transplantation in Sickle Cell Disease Patients
This study is testing if lower levels of a drug called alemtuzumab in sickle cell disease patients who receive a stem cell transplant can lead to a higher chance of their body rejecting the new cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | alemtuzumab, Chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05905770 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between alemtuzumab levels and T cell chimerism in patients with sickle cell disease undergoing non-myeloablative allogeneic stem cell transplantation. The study focuses on patients receiving a conditioning regimen of alemtuzumab and total body irradiation, aiming to determine if lower alemtuzumab levels correlate with an increased risk of graft rejection. By monitoring T cell chimerism levels post-transplant, the study seeks to identify predictors of successful transplantation outcomes. The findings could help optimize treatment protocols for sickle cell disease patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 years and older with a confirmed diagnosis of sickle cell disease who are scheduled for a matched sibling donor stem cell transplant.
Not a fit: Patients who are not planning to undergo a non-myeloablative stem cell transplant or those with other underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of stem cell transplants for sickle cell disease by identifying optimal alemtuzumab levels.
How similar studies have performed: While the approach of using alemtuzumab in stem cell transplantation is established, this specific correlation with T cell chimerism in sickle cell disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * No specific exclusion criteria
Where this trial is running
Amsterdam
- Amsterdam Medical Centre — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erfan Nur, MD, PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Erfan Nur, MD, PhD
- Email: e.nur@amsterdamumc.nl
- Phone: 0031-20 - 4442604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.