Clinical trial · Interventional
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
NCT04281199CI-TRIAL-00120669active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hematopoietic Cell Transplantation | Procedure | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Tomotherapy | Radiation | — | UNRESOLVED |
| Total-Body Irradiation | Radiation | — | UNRESOLVED |
| Volume Modulated Arc Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (TBI, IMRT)
- description
- Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.
- interventionNames
- Procedure: Hematopoietic Cell Transplantation
- Radiation: Intensity-Modulated Radiation Therapy
- Radiation: Tomotherapy
- Radiation: Total-Body Irradiation
- Radiation: Volume Modulated Arc Therapy
Primary outcomes (1)
- measure
- Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)
- timeFrame
- Up to 1 year post transplant
- description
- Will be summarized using percentage and its 95% confidence interval.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.