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TBI Using IMRT and Cyclophosphamide for Severe Systemic Sclerosis

This study is testing a new way to prepare people with severe systemic sclerosis (a disease that causes hardening of the skin and organs) for a stem cell transplant. It uses a special type of radiation called Intensity-Modulated Radiation Therapy (IMRT) for Total-Body Irradiation (TBI), which aims to deliver radiation more precisely and protect healthy organs like the lungs and kidneys. You would also receive cyclophosphamide, a chemotherapy drug, before the stem cell transplant. Researchers want to see if this combination is safe and feasible, and how well it protects your lungs and kidneys. The study plans to enroll 15 participants between 18 and 65 years old who have a good performance status (Karnofsky performance status (KPS) >= 70). The main goals are to measure the radiation dose to your lungs and kidneys.

Study design
This is an early-phase interventional study planning to enroll 15 participants. It is testing a specific treatment approach for severe systemic sclerosis.
What's involved
You would receive Total-Body Irradiation (TBI) using IMRT twice daily for two days, followed by cyclophosphamide for two days, and then undergo a stem cell transplant on day 0.
Compensation
Not stated in the trial record.
Follow-up
You would be followed up on days 30 and 100 after the stem cell transplant.

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NCT04380831

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

Active, Not Recruiting
EARLY_PHASE1Ages 18–65InterventionalTreatment
City of Hope Medical Center
~15 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationCyclophosphamideIntensity-Modulated Radiation TherapyTotal-Body Irradiation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean lung dose
Measured over Up to day 100
+1 more outcome measured

Conditions

Systemic Scleroderma

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Systemic Scleroderma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeffrey Y Wong · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Karnofsky performance status (KPS) \>= 70
Systemic sclerosis patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) per City of Hope (COH) guidelines and standard operating procedures (SOP) for autologous hematopoietic cell transplant
Patients must be suitable for TBI conditioning regimens as part of transplant per radiation the referring hematologist
Patients must have adequate organ function for HCT as determined by the hematologist
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent

Exclusion

Patients should not have any uncontrolled illness including ongoing or active infection
Prior history of radiation therapy must be presented to study principal investigator (PI) for eligibility determination
Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

What this trial measures

  • Mean lung doseUp to day 100

    The study will be deemed feasible if \>= 80% of patients complete the intensity modulation radiation therapy (IMRT) to the total dose of 800 cGy, mean lung and kidney doses are limited to 200 cGy or less.

  • Mean kidney doseUp to day 100

    The study will be deemed feasible if \>= 80% of patients complete the IMRT to the total dose of 800 cGy, mean lung and kidney doses are limited to 200 cGy or less.