Clinical trial · Interventional
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
A Phase II Single-Arm Study of Total Body Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) and Image Guided Radiation Therapy (IGRT)
NCT04509765CI-TRIAL-00110287completedN/AResults postedClinicalTrials.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)
Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linac Based VMAT TBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Hematologic Malgnancies
- interventionNames
- Radiation: Linac Based VMAT TBI
Primary outcomes (1)
- measure
- Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung
- timeFrame
- Up to 1 year post-transplant
- description
- Excellent coverage while sparing the lung is quantified by meeting the following dosimetric parameters (all parameters must be met): 1. V100%= \>90% (90% of PTV volume getting 100% of the dose). 2. D98\>85% (98% of the volume getting at least 85% of the dose). 3. Mean Lung dose \<900cGy.
Secondary outcomes (6)
- measure
- Event Free Survival (EFS)
- timeFrame
- Up to 1 year post-transplant
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 2. 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. 3. Referral from the blood and marrow transplant (BMT) program for full-dose TBI, who meet inclusion and exclusion criterial per BMT SOPs. 1. BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation. 2. 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: 1. Patient receiving less than 1200 cGy of TBI 2. Previous history of thoracic radiation therapy including previous TBI 3. All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study. 4. Prisoners 5. Patient not meeting transplant criteria per BMT physician.
References
Publications (0)
Data not yet available
No reference posted for this study.