Pure Global AI
NCT06358638Recruiting

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach: Adding Daratumumab for Patients With Anti-donor Red Cell AntibodY
Children's National Research InstitutePhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Sickle Cell Disease
Drug/Device/Intervention
Daratumumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Children's National Research Institute
Location
Washington, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Apr 01, 2024
End date
Sep 01, 2054
Enrollment
12 participants
Primary outcome

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.

Summary

This multicenter prospective study seeks to determine if daratumumab given, prior to
 HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body
 irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety
 profile in patients with anti-donor red blood cell antibodies, achieving an event-free
 survival similar to transplanted patients without such antibodies.

ICD-10 classifications
Sickle-cell disordersOther sickle-cell disordersSickle-cell traitSickle-cell anaemia with crisisSickle-cell anaemia without crisis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06358638
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06358638 through Pure Global AI's free database. This Phase 2 trial is sponsored by Children's National Research Institute and is currently Recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.