Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07616154
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide 50mg — DRUG
    IV
  • Abatacept — DRUG
    IV
  • Alemtuzumab — DRUG
    IV
  • Hydroxyurea — DRUG
    IV
  • Thiotepa — DRUG
    IV
  • Filgrastim — DRUG
    IV
  • Sirolimus — DRUG
    IV
  • Azathioprine — DRUG
    IV
  • TBI — RADIATION
    Radiaiton therapy
  • Hematopoietic Progenitor Cell Infusion — PROCEDURE
    Hematopoietic Progenitor Cell Infusion

Study Details

The purpose of this study it to evaluate a reduced toxicity conditioning regimen for haploidentical donor HCT followed by a GVHD prophylaxis regimen comprising of post-transplant cyclophosphamide, sirolimus and abatacept with the goal to improve the GVHD-free rejection-free survival (GRFS) to greater than 90% after haploidentical donor HCT in children and young adults with SCD. Primary Objective: \- To assess the GVHD-free and rejection free survival (GRFS) after haploidentical donor HCT in children and young adults with SCD. Secondary Objectives: * Assess the overall survival (OS) and disease-free survival (DFS) after haploidentical donor HCT for SCD. * Estimate incidence and severity of acute and chronic GVHD after haploidentical donor HCT for SCD. * Assess the neutrophil and platelet engraftment kinetics after haploidentical donor HCT for SCD.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2034
Completion
Sep 30, 2035

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAPSCD Treatment

Primary Outcome Measure

GVHD-free and rejection free survival (GRFS) [ Time Frame: Up to 3 years after HCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St Jude Children's Research HospitalMemphisTennessee38105
Akshay Sharma, MD
[email protected]
866-278-5833
Akshay Sharma, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
St Jude Children's Research Hospital· Memphis, TN

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