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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: Active Phase 2 study of Sickle Cell Disease, sponsored by Emory University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Immune suppression-free, rejection-free survival is defined as rejection-free survival off all systemic immunosuppressive agents. Participants who are off systemic immune suppression by 2-years post-transplant will be considered as being immune suppression free.

Conditions Studied

Sickle Cell Disease

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

FieldValue
Enrollment Target 43 participants
Start Date 2019-03-22
Est. Completion 2026-11
Phase Phase 2
Emory University

1,208 total trials

What the registry record for NCT04018937 still lists

NCT04018937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower).

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 lists 15 locations in 14 states (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.

Learn More About Clinical Trials

Similar trials for Sickle Cell Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04018937's enrollment target sits among peer trials

43 121st of 213 higher than 93 of 213 other Sickle Cell Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04018937, the US trial registry maintained by the National Library of Medicine. NCT04018937 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.