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Study details
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Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody

Children's National Research Institute
NCT IDNCT06358638ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

12

Study length

about 31 years

Ages

2–25

Locations

1 site in DC

What this study is about

This trial is testing if daratumumab, given before a bone marrow transplant from an identical sibling donor with alemtuzumab, low dose total body irradiation, and sirolimus, can prevent red blood cell problems in people with anti-donor antibodies. The goal is to achieve similar survival rates as those who have transplants without these antibodies.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Receive Total Body Irradiation
  • 2.Take Alemtuzumab
  • 3.Take Daratumumab
  • +1 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

alemtuzumab, daratumumab, sirolimus

Drug routes

injection (Injection), infusion, injection, intravenous

Endpoints

Primary: To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies.

Secondary: To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater.

Procedures

radiation