A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT

Not Applicable

Active, not recruiting

• Conditions: Hematologic Malignancy
• Interventions: Radiation: Linac Based VMAT TBI

• Registration Number: NCT04509765
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-09-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Hematologic Malgnancies	Linac Based VMAT TBI	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve excellent coverage while sparing the lung	Up to 1 year post-transplant	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 Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	Up to 1 year post-transplant
Cumulative incidence rate of idiopathic pneumonia syndrome	Up to 100 days post-transplant	Non-infectious pneumonia syndrome is defined by the American Thoracic Society as at least 1 of the following without concurrent infection detected on blood culture, broncoalveolar lavage, lung biopsy or sputum: 1. There must also be the absence of cardiac dysfunction, acute renal failure, or iatrogenic fluid overload as etiology for pulmonary dysfunctionMultilobar infiltrates on chest radiograph or computed tomography (CT); 2. Symptoms and signs of pneumonia including dyspnea, cough, cyanosis, hypoxia or pyrexia; 3. New or increased restrictive patters on pulmonary function testing or increased alveolar to arterial oxygen difference
Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy	Up to 150 days post-transplant
Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant	100 days post-transplant
Proportion of patients who have achieved a maximum dose to 2cc of the entire body (D2cc) < 130% of Rx dose.	Up to 150 days post-transplant
Proportion of patients who have achieved a maximum dose to 0.03cc of OARs < 120% of Rx dose.	Up to 150 days post-transplant

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States