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

Hematologic Malignancy Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04509765
• Other study ID #: 19-00664
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: September 9, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 9, 2024
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Radiation:
• Linac Based VMAT TBI
Use of linac based Volumetric Arc Therapy (VMAT) to deliver Total Body Irradiation (TBI). The study intervention is a VMAT based delivery technique using a 6 MV photon beam from a Varian TrueBeam® (Palo Alto, CA) equipped with a Millennium multi-leaf collimation (MLC) system3. TBI will be delivered using a Varian TrueBeam linear accelerator with photon beam VMAT capability. VMAT is a radiation technique combining dynamic photon fluence modulation using multi-leaf collimation (MLC) with gantry rotation to deliver a highly conformal dose distribution with improved target coverage and sparing of organs at risk (OARs).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve excellent coverage while sparing the lung	Excellent coverage while sparing the lung is quantified by meeting the following dosimetric parameters (all parameters must be met): V100%= >90% (90% of PTV volume getting 100% of the dose).; D98>85% (98% of the volume getting at least 85% of the dose).; Mean Lung dose <900cGy.	Up to 1 year post-transplant
Secondary	Cumulative incidence rate of idiopathic pneumonia syndrome	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: 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); Symptoms and signs of pneumonia including dyspnea, cough, cyanosis, hypoxia or pyrexia; New or increased restrictive patters on pulmonary function testing or increased alveolar to arterial oxygen difference	Up to 100 days post-transplant
Secondary	Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant		100 days post-transplant
Secondary	Event Free Survival (EFS)		Up to 1 year post-transplant
Secondary	Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy		Up to 150 days post-transplant
Secondary	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
Secondary	Proportion of patients who have achieved a maximum dose to 0.03cc of OARs < 120% of Rx dose.		Up to 150 days post-transplant