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RECRUITING
NCT04380831
EARLY_PHASE1

TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.

Official title: Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2022-02-24

Completion Date

2026-12-22

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

DRUG

Cyclophosphamide

Undergo HSCT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo TBI using IMRT

PROCEDURE

Total-Body Irradiation

Undergo TBI using IMRT

Locations (1)

City of Hope Medical Center

Duarte, California, United States