A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung |
33 | — |
| SECONDARY Event Free Survival (EFS) |
86 | — |
| SECONDARY Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose. |
26 | — |
| SECONDARY Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome |
— | — |
| SECONDARY Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose. |
33 | — |
| SECONDARY Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant |
7 | — |
| SECONDARY Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy |
33 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (HPC) transplant, in which the protocol requires >12 Gray of TBI, as part of the conditioning regimen.
a. Conditioning regimens outlined per BMT SOP: CLNTX007: Selection of Conditioning Regimens for Blood and Marrow Transplantation - ADULTS.
- Referral from the blood and marrow transplant (BMT) program for full-dose TBI, who meet inclusion and exclusion criterial per BMT SOPs.
- BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation.
- Patients undergo pre-transplant testing, as defined in BMT SOPs:CLNAL002: Related (MRD, Haplo) Allogeneic Recipient Evaluation and Management or CLNAL011: Unrelated (MUD, MMUD, CBU) Allogeneic Recipient Evaluation and Management, per below.
i. BMT SOP's include baseline pulmonary function tests (PFTs). Patient with decreased FVC, FEV1 and or DLCO (adjusted for hemoglobin) or pulmonary history will have pulmonary consult, at the discretion of the BMT physician prior to undergoing myeloablative radiation.
ii. Medical history and physical by BMT provider.
iii. The following laboratory tests (additional testing may be required for positive results):
- ABO group and Rh type
- Red Blood Cell Antibody Screen.
- HLA typing and confirmatory typing
- HLA antibody screen, class I and II, performed within 30 days of transplant.
- Complete blood count (CBC) with differential.
- Basic metabolic panel, including glucose and to include at a minimum electrolyte evaluation of potassium, calcium, magnesium, and phosphorus.
- Blood urea nitrogen (BUN)
- Creatinine
- Liver Function Tests including: Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Lactate dehydrogenase (LDH), Albumin, Total Protein, Urinalysis
Exclusion Criteria
- Patient receiving less than 1200 cGy of TBI
- Previous history of thoracic radiation therapy including previous TBI
- All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
- Prisoners
- Patient not meeting transplant criteria per BMT physician.
Data sourced from ClinicalTrials.gov (NCT04509765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.