Clinical trial
RH Genotype Matched Red Cells for Patients With Sickle Cell Disease and Anti-D
Name
19-016566
Description
This is a pilot study to evaluate the feasibility and safety of providing RH genotype matched D+ Red Blood Cells (RBCs) to chronically transfused patients with sickle cell disease (SCD) who type D+ but have formed anti-D and are currently transfused with D- RBC (Red Blood Cell) units.
Trial arms
Trial start
2020-07-08
Estimated PCD
2024-12-01
Trial end
2025-07-01
Status
Recruiting
Phase
Early phase I
Treatment
D+ RH genotype matched red cell units for transfusion
Chronically transfused patients with SCD and anti-D will receive D+ RH genotyped matched red cell units for transfusion in addition to standard C, E, and K antigen matching and being hemoglobin S negative, which is the Children's Hospital of Philadelphia institutional standard of care for patients with SCD. RH genotyping of donor units will be performed by the New York Blood Center (NYBC) Immunogenetics laboratory.
Arms:
D+ RH genotype matched Red Blood Cell Transfusion
Size
20
Primary endpoint
Feasibility and safety of providing RH genotype matched D+ RBCs to patients with SCD who type D+ but have formed anti-D
5 years
Eligibility criteria
Inclusion Criteria:
* Subjects age \> 8 years old
* Diagnosis of SCD, all genotypes
* Require chronic red cell transfusion therapy
* History of anti-D
* RH genotype predicts D+ expression
Exclusion Criteria:
* Rare RH genotype that would preclude sufficient RBC units
* Antigen negative requirements due to alloimmunization that would preclude sufficient RBC units
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-08-07
1 organization
Organization
Children's Hospital of Philadelphia