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ACTIVE NOT RECRUITING
NCT05384756
PHASE1

TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2022-07-13

Completion Date

2026-12-01

Last Updated

2026-01-05

Healthy Volunteers

Yes

Interventions

DRUG

Alemtuzumab

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HCT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo TMLI

DRUG

Sirolimus

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States