Clinical trial NCT04509765: A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
Official title: A Phase II Single-Arm Study of Total Body Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) and Image Guided Radiation Therapy (IGRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Myeloablative Treatment
Total Body Irradiation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (HPC).

This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who achieve excellent coverage while sparing the lung
timeFrame: Up to 1 year post-transplant
Secondary outcomes:
measure: Cumulative incidence rate of idiopathic pneumonia syndrome
timeFrame: Up to 100 days post-transplant
measure: Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant
timeFrame: 100 days post-transplant
measure: Event Free Survival (EFS)
timeFrame: Up to 1 year post-transplant
measure: Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy
timeFrame: Up to 150 days post-transplant
measure: Proportion of patients who have achieved a maximum dose to 2cc of the entire body (D2cc) < 130% of Rx dose.
timeFrame: Up to 150 days post-transplant
measure: Proportion of patients who have achieved a maximum dose to 0.03cc of OARs < 120% of Rx dose.
timeFrame: Up to 150 days post-transplant
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Naamit Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: