Adding Azathioprine/Hydroxyurea Preconditioning to Alemtuzumab/TBI to Reduce Risk of Graft Failur… (NCT05249452) | Clinical Trial Compass
CompletedNot Applicable
Adding Azathioprine/Hydroxyurea Preconditioning to Alemtuzumab/TBI to Reduce Risk of Graft Failure in MSD HSCT in Adult SCD Patients
Netherlands20 participantsStarted 2018-03-08
Plain-language 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 in improved disease-free survival and donor chimerism after allo-SCT in SCD patients. Furthermore, the investigators will evaluate whether azathioprine/hydroxyurea preconditioning leads to more patients being able to taper and discontinue sirolimus at 12 months post-transplantation.
Who can participate
Age range16 Years – 60 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Disease-free survival
Timeframe: 1 year post-transplantation
Trial details
NCT IDNCT05249452
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)