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NCT06358638 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Sickle Cell Disease, sponsored by Children's National Research Institute.

Recruiting
Registry status
Phase 2
Development phase
12
Enrollment target
1
Study location

NCT06358638 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 12 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06358638, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Children's National Research Institute.

RECRUITING
Registry status
Phase 2
Development phase
12 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Sirolimus
  • DRUG Alemtuzumab
  • DRUG Daratumumab
  • RADIATION Total Body Irradiation

Study Locations (1)

District of Columbia

  • Children's National Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2024-04-03
Est. Completion 2054-09
Phase Phase 2

What the Registry Record Tells You About NCT06358638

The ClinicalTrials.gov registry entry for NCT06358638 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 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 (96% lower). The listed sponsor is Children's National Research Institute, which has 92 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 4 interventions - of which Sirolimus is the first listed.

NCT06358638 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT06358638 about?

NCT06358638 is a clinical study titled "Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody". 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 re...

What is the current status of trial NCT06358638?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-04-03. Estimated completion is 2054-09.

What conditions does trial NCT06358638 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT06358638?

The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Daratumumab (DRUG), Total Body Irradiation (RADIATION).

Who is sponsoring clinical trial NCT06358638?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06358638 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.