NCT04281199Active, not recruitingPhase 1
TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT
Multi-Institutional Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) (VMAT or Tomotherapy) for Allogeneic HSCT With New Lung Radiation Dose Guidelines to Prevent Pul Toxicities
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
This trial studies how well radiation therapy techniques, volumetric modulated arc therapy (VMAT) and tomotherapy, work to reduce doses to the lung compared to standard total body irradiation methods to prevent pulmonary toxicities. Standard total body irradiation is limited in its ability to spare normal organs, with only the lung being partially spared by lung blocks and risks the development of pulmonary toxicities. Reducing the doses to the lung using VMAT or tomotherapy may improve survival and decrease long term lung side effects in patients undergoing stem cell transplant.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 20 Feb 2020
- Start date
- 28 Feb 2020
- Primary completion date
- 24 Jun 2027
- Lead sponsor
- City of Hope Medical Center
- NCT number
- NCT04281199
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 28 Feb 2020 to the primary completion date, 24 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients should not have any uncontrolled illness including ongoing or active infection
Other
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Who the study is looking for
- 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
Age in the registry: 12 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.