Status:
COMPLETED
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
Lead Sponsor:
NYU Langone Health
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.
Detailed Description
Total Body Irradiation (TBI) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for Allogeneic Stem Cell Transplant (ASCT). When TBI is used as part of a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04509765
Start Date
September 22 2020
End Date
February 11 2025
Last Update
April 9 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016