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

NCT04509765 | Completed Results DMC FDA Device

• 1 other identifier: 19-00664
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematologic Malignancy

Keywords

Myeloablative Treatment; Total Body Irradiation

Outcome Measures

Primary Outcomes (1)

• 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): 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.

  Up to 1 year post-transplant

Secondary Outcomes (6)

• Event Free Survival (EFS)

  Up to 1 year 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

• Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome

  Up to 100 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

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

  100 days post-transplant

Study Arms (1)

Patients with Hematologic Malgnancies

EXPERIMENTAL

Radiation: Linac Based VMAT TBI

Interventions

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).

Patients with Hematologic Malgnancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient receiving less than 1200 cGy of TBI

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Naamit Kurshan Gerber, MD
• Organization: NYU Langone Health

Naamit.gerber@nyulangone.org

212-731-5003

Study Officials

• Naamit Gerber, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: September 22, 2020
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to naamit.gerber@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)