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Completed

NCT Number: NCT04509765

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

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

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Linac Based VMAT TBI

Radiation

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).

Primary outcomes

  1. Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung

    Time frame: 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):

    • 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.

Secondary outcomes

  1. Event Free Survival (EFS)

    Time frame: Up to 1 year post-transplant

    Interval from day of transplant to date of first objective disease progression or relapse or death from any cause. Subjects without these failures will be censored at the last date that they were assessed and deemed failure free.

  2. Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose.

    Time frame: Up to 150 days post-transplant

    Number of participants with Maximum dose to 2cc of the entire body (D2cc) <130% of Rx dose

  3. Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome

    Time frame: 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:

    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

  4. Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose.

    Time frame: Up to 150 days post-transplant

    Number of participants with Maximum dose to 0.03cc of organs at risk <120% of Rx dose

  5. Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant

    Time frame: 100 days post-transplant

    Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant

  6. Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy

    Time frame: Up to 150 days post-transplant

    Number of participants with mean dose of <11Gy (1100 cGy) to either kidney

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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