RecruitingPhase 1NCT05384756

TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

A Pilot Study of Nonmyeloablative Regimen Using Total Marrow and Lymphoid Irradiation for Irradiation Sparing of Bystander Organs in Hematopoietic Cell Transplantation From Matched Related or Unrelated Donor in Patients With Sickle Cell Disease


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alemtuzumab, a procedure called Hematopoietic Cell Transplantation, and others for people with sickle cell disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlemtuzumab

Given IV

PROCEDUREHematopoietic Cell Transplantation

Undergo HCT

RADIATIONIntensity-Modulated Radiation Therapy

Undergo TMLI

DRUGSirolimus

Medication to prevent the development of graft-versus-host disease (GVHD)


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05384756


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