Actively Recruiting
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
Led by City of Hope Medical Center · Updated on 2026-03-30
15
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Karnofsky performance status (KPS) 70 or higher
- Diagnosis of systemic sclerosis and evaluated within 30 days before starting conditioning regimen
- Candidates for total body irradiation and cyclophosphamide per City of Hope guidelines for autologous hematopoietic cell transplant
- Suitable for total body irradiation conditioning as determined by radiation and hematology specialists
- Adequate organ function for hematopoietic cell transplant as assessed by hematologist
- Women of child-bearing potential and men must agree to use effective contraception before and for six months after study participation
- Ability to understand the treatment and willingness to sign informed consent
You will not qualify if you...
- Presence of any uncontrolled illness, including ongoing or active infections
- Prior radiation therapy history must be reviewed by the study principal investigator for eligibility
- Pregnant women are excluded due to risks from total body irradiation
- Inability to comply with safety monitoring requirements as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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