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NCT04018937 · ClinicalTrials.gov registry record · Phase 2
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation
A Phase 2 study of Sickle Cell Disease, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 15
- Study locations
NCT04018937 is a Phase 2 study of Sickle Cell Disease that is active but no longer recruiting, run by Emory University. The registered enrollment target is 43 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower). The trial reports 15 study locations across 14 states.
The verdict
NCT04018937, a Phase 2 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study aims to enroll 58 pre-adolescent (\<13 years) pediatric participants with sickle cell disease (SCD) who have a pre-adolescent sibling bone marrow donor. All participants will go through a pre-transplant evaluation to find out if there are health problems that will keep them from being able to receive the transplant. It usually takes 2 to 3 months to complete the pre-transplant evaluation and make the arrangements for the transplant. Once they are found to be eligible for transplant, participants will be admitted to the hospital and will start transplant conditioning. Conditioning is the chemotherapy and other medicines given to prepare them to receive donor cells. It prevents the immune system from rejecting donor cells. Conditioning will start 21 days before transplant. Once they complete conditioning, participants will receive the bone marrow transplant. After the transplant, participants will stay in the hospital for 4-6 weeks. After they leave the hospital, participants will be followed closely in the clinic. Outpatient treatment and frequent clinic visits usually last 6 to 12 months. Routine medical care includes at least a yearly examination for many years after transplant by doctors and nurses familiar with sickle cell disease and transplant. The researchers will collect and study information about participants for 2 years after transplant.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Alemtuzumab
Study Locations (15)
North Carolina
- University of North Carolina Medical Center - Chapel Hill
- Atrium Health Levine Cancer Institute - Charlotte
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Children's - Phoenix
Connecticut
- Yale University, Yale Cancer Center - New Haven
District of Columbia
- Children's National Hospital - Washington D.C.
Georgia
- Children's Healthcare of Altanta - Atlanta
Illinois
- University of Chicago - Chicago
Indiana
- Riley Children's Health/Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-03-22 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04018937
The ClinicalTrials.gov registry entry for NCT04018937 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 3 interventions - of which Fludarabine is the first listed.
NCT04018937 reports 15 study locations spanning 14 distinct geographic areas - top geographies include North Carolina, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04018937 about?
NCT04018937 is a clinical study titled "Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation". This study aims to enroll 58 pre-adolescent (\<13 years) pediatric participants with sickle cell disease (SCD) who have a pre-adolescent sibling bone marrow donor. All participants will go through a pre-transplant evaluation to find out if there are health problems that will keep them from being abl...
What is the current status of trial NCT04018937?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-03-22. Estimated completion is 2026-11.
What conditions does trial NCT04018937 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04018937?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT04018937?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04018937 being conducted?
This trial has 15 study locations across Alabama, Arizona, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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