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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Total Body Irradiation
  • 2.Take Alemtuzumab
  • 3.Take Daratumumab
  • +1 more
PhasePhase 2
DrugAlemtuzumab
Routeinjection
Primary goalTo 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

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low12%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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