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NCT05384756 · ClinicalTrials.gov registry record · Phase 1

TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

A Phase 1 study of Sickle Cell Disease, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 1
Development phase
2
Enrollment target
1
Study location

NCT05384756 is a Phase 1 study of Sickle Cell Disease that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 2 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05384756, a Phase 1 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
2 participants
Enrollment target
1
Study location

Study Summary

This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant is a procedure in which a person receives blood stem cells, which make any type of blood cell. A conditioning regimen may include chemotherapy, monoclonal antibody therapy, and radiation to the entire body. It helps make room in the patient's bone marrow for new blood stem cells to grow, and helps prevent the patient's body from rejecting the transplanted cells. Alemtuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Graft-versus-host disease (GVHD) is a complication that may occur after hematopoietic cell transplantation (HCT) in which donated cells view the recipient's cells as foreign and attack them. Giving TMLI and alemtuzumab may help reduce organ damage that can be caused by radiation and decrease the risk of GVHD.

Conditions Studied

Sickle Cell Disease

Interventions

  • DRUG Sirolimus
  • DRUG Alemtuzumab
  • RADIATION Intensity-Modulated Radiation Therapy
  • PROCEDURE Hematopoietic Cell Transplantation

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2022-07-13
Est. Completion 2026-12-01
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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What the Registry Record Tells You About NCT05384756

The ClinicalTrials.gov registry entry for NCT05384756 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 2 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 (99% lower). The listed sponsor is City of Hope Medical Center, which has 582 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.

NCT05384756 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05384756 about?

NCT05384756 is a clinical study titled "TMLI and Alemtuzumab for Treatment of Sickle Cell Disease". This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant i...

What is the current status of trial NCT05384756?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-07-13. Estimated completion is 2026-12-01.

What conditions does trial NCT05384756 study?

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

What interventions are being tested in trial NCT05384756?

The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Hematopoietic Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT05384756?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05384756 being conducted?

This trial has 1 study location across California. 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.