Status:
COMPLETED
Adding Azathioprine/Hydroxyurea Preconditioning to Alemtuzumab/TBI to Reduce Risk of Graft Failure in MSD HSCT in Adult SCD Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16-60 years
Brief Summary
In this study the investigators will prospectively investigate whether the addition of a 3-months long preconditioning with azathioprine to the alemtuzumab/TBI non-myeloablative conditioning results i...
Detailed Description
Matched sibling donor (MSD) transplantation with non-myeloablative conditioning (1 mg/kg alemtuzumab and 300 cGy total body irradiation (TBI)) using peripheral blood derived stem cells has shown promi...
Eligibility Criteria
Inclusion
- SCD patients with an HLA-identical matched sibling donor eligible for allogeneic stem cell transplantation.
- Age 16 - 60 years
- Good performance status (ECOG 0 or 1; Karnofsky and Lansky 70-100)
- Patients and donors (MSD) must be able to sign consent forms for receiving and donating hematopoietic stem cells respectively. The sibling donor should be willing to donate.
- Patients must be geographically accessible and willing to participate in all stages of treatment.
- Eligible diagnoses: Patients with sickle cell disease such as sickle cell anemia (Hb SS), Hb/Sβ0-thalassemia, Hb/Sβ+-thalassemia, HbSC disease, HbSE disease, HbSD disease and Hemoglobin SO- Arab disease.
Exclusion
- Poor performance status (ECOG\>1).
- Poor cardiac function: left ventricular ejection fraction\<35%.
- Poor pulmonary function: FEV1 and FVC\<40% predicted.
- Poor liver function: direct bilirubin \>3.1 mg/dl
- HIV-positive
- Women of childbearing potential who currently are pregnant (Beta-HCG+) or who are not practicing adequate contraception.
- Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow-up. However, patients with history of stroke and significant cognitive deficit, that would preclude giving informed consent or assent will not be excluded, if they have a family member or significant other with Power of Attorney to also consent of their behalf.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05249452
Start Date
March 8 2018
End Date
December 1 2024
Last Update
October 2 2025
Active Locations (1)
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1
Amsterdam Medical Centre
Amsterdam, Netherlands