A Trial to Assess Haploidentical T-depleted Stem Cell Transplantation in Patients With SCD
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HbS Disease
- Hemoglobin S Disease
- Sickle Cell Anemia
- Sickle Cell Disease
- Sickle Cell Disorders
- Sickling Disorder Due to Hemoglobin S
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients who fulfill inclusion criteria will be stratified according to donor availability. Patients with a matched sibling donor (MSD; defined as 8/( or 10/10 allelic match) will be stratified into the control arm.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 35 years
- Gender
- Both males and females
Description
Can an ?/ß depleted T-Haplo-HSCT with regard to disease free survival, adverse events and safety be considered equivalent to a matched sibling donor transplantation (MSD), in order to offer cure for the majority of patients with sickle cell disease. The main questions of this trial are: Safety of a ...
Can an ?/ß depleted T-Haplo-HSCT with regard to disease free survival, adverse events and safety be considered equivalent to a matched sibling donor transplantation (MSD), in order to offer cure for the majority of patients with sickle cell disease. The main questions of this trial are: Safety of a ?/ß T-depleted haploidentical HSCT Incidence of acute and chronic GvHD Rate of rejection Immune reconstitution Fertility It is expected that the use of TCR??+ and CD19+ depleted haploidentical cell grafts in combination with the less aggressive and well tolerated conditioning regimen needed for patient preparation will be associated with a low risk of grade II-IV aGVHD and no extensive cGvHD, no graft failure and increase speed, spectrum and functionality of immune system reconstitution. This is supposed to reduce the incidence of severe infections leading to lower rates of transplantation related mortality (TRM).
Tracking Information
- NCT #
- NCT04201210
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Selim Corbacioglu, MD University Hospital of Regensburg
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