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New radiation technique may make stem cell transplants safer for scleroderma patients

NCT ID NCT04380831

Disease control Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early study tests whether a precise type of total body radiation (IMRT) combined with chemotherapy can safely prepare the body for a stem cell transplant in people with severe systemic sclerosis (scleroderma). The goal is to reduce radiation exposure to the lungs and kidneys while still controlling the disease. Only 15 participants will be enrolled to check if the approach is feasible and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cyclophosphamide (chemotherapy) and total body radiation (IMRT) before stem cell transplant
What this could lead to
If it works, this could lead to a safer stem cell transplant method for severe scleroderma, reducing side effects to the lungs and kidneys.
What could go wrong
This is a very early (Phase 1) pilot study with only 15 people, so it is too small to prove effectiveness. The main goal is just to see if the approach is feasible and safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic scleroderma

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.