Actively Recruiting
RElated Haplo-DonoR Haematopoietic stEm Cell Transplantation for Adults With Severe Sickle Cell Disease
Led by King's College Hospital NHS Trust · Updated on 2023-05-10
120
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
K
King's College Hospital NHS Trust
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the clinical and cost effectiveness of Haploidentical Stem Cell Transplantation (SCT) for adults with severe sickle cell disease (SCD), who have failed other therapies or are intolerant of existing therapies or require chronic transfusions to prevent on-going complications of SCD.
CONDITIONS
Official Title
RElated Haplo-DonoR Haematopoietic stEm Cell Transplantation for Adults With Severe Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 60 18 years
- Confirmed haploidentical donor
- Severe sickle cell disease with at least one of: significant stroke or neurologic deficit lasting > 24 hours, 62 acute chest syndromes in 2 years despite treatment, 63 severe pain crises per year in 2 years despite care, regular transfusion therapy (8+ blood transfusions/year) to prevent complications, difficulty continuing transfusions due to antibodies or rare blood type, intolerance to hydroxycarbamide or transfusion therapy, or established end organ damage related to sickle cell disease
- Fit for haploidentical stem cell transplant with Karnofsky score 60 60, cardiac function (LVEF 60 45% or shortening fraction 60 25%), lung function (FEV1, FVC, TLCO 60 50%), renal function (EDTA GFR 60 40 ml/min/1.73m2), hepatic function (ALT <3 times upper limit of normal, bilirubin <2 times upper limit except sickle-related hemolysis), and no radiological cirrhosis
- Written informed consent
You will not qualify if you...
- Fully matched sibling donor
- Previous bone marrow transplant
- Pregnancy or breastfeeding
- Participants able to conceive who do not agree to use effective contraception
- Clinically significant donor specific HLA antibodies
- HIV infection or active Hepatitis B or C
- Uncontrolled infection including bacterial, fungal, or viral
- Participation in another interventional trial in the last 3 months
- Pre-existing condition increasing risk of haploidentical stem cell transplant as judged by local investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
King's College Hospital
London, United Kingdom
Actively Recruiting
Research Team
V
Victoria Potter, BSc, MBBS, FRACP, FRCPA
CONTACT
D
Daryl Hagan, BSc, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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