New radiation technique aims to protect lungs during stem cell transplants
NCT ID NCT04281199
First seen Jun 26, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This early-phase study tests a new way to deliver total body radiation before a stem cell transplant for people with acute leukemia or myelodysplastic syndrome. The goal is to reduce radiation to the lungs to prevent serious lung damage. Twenty participants will receive intensity-modulated radiation therapy (IMRT) instead of standard total body irradiation, and researchers will track side effects and treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intensity-modulated radiation therapy (IMRT) with total body irradiation
- What this could lead to
- If successful, this approach could reduce lung side effects and improve survival for patients needing a stem cell transplant.
- What could go wrong
- This is a small, early-phase pilot study with only 20 participants, so results may not apply broadly. The new radiation technique may still cause lung problems or other side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Feb 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 * Acute leukemia or myelodysplastic patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) or TBI-etoposide (VP16) per City of Hope (COH) standard operating procedure (SOP) for allogeneic hematopoietic stem cell transplant * Patients must be suitable for TBI conditioning regimens as part of transplant per the referring hematologist * Patients must have adequate organ function for hematopoietic cell transplantation (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 * The effects of total body radiation on the developing fetus are unknown. For this reason, 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. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Although not mandated by the protocol, the results of the imaging scans and labs (complete blood count \[CBC\], comprehensive metabolic panel \[CMP\]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry * Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to TBI * All patients with prior radiotherapy need to be reviewed with the principal investigator (PI) to determine eligibility * Prior therapy with chemotherapeutic agents is allowed * DONOR: Donor evaluation and eligibility will be assessed per current COH standard operating procedure Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * Prior history of radiation therapy must be presented to study 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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