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

Primary Purpose

Hematologic Malignancy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Linac Based VMAT TBI

About this trial

This is an interventional treatment trial for Hematologic Malignancy focused on measuring Myeloablative Treatment, Total Body Irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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:

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.

Sites / Locations

NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Hematologic Malgnancies

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant

Event Free Survival (EFS)

Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy

Proportion of patients who have achieved a maximum dose to 2cc of the entire body (D2cc) < 130% of Rx dose.

Proportion of patients who have achieved a maximum dose to 0.03cc of OARs < 120% of Rx dose.

Full Information

NCT ID

NCT04509765

First Posted

August 10, 2020

Last Updated

March 23, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04509765

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2020 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancy

Keywords

Myeloablative Treatment, Total Body Irradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with Hematologic Malgnancies

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Linac Based VMAT TBI

Intervention Description

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 Outcome Measure Information:

Title

Proportion of patients who achieve excellent coverage while sparing the lung

Description

Time Frame

Up to 1 year post-transplant

Secondary Outcome Measure Information:

Title

Cumulative incidence rate of idiopathic pneumonia syndrome

Description

Time Frame

Up to 100 days post-transplant

Title

Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant

Time Frame

100 days post-transplant

Title

Event Free Survival (EFS)

Time Frame

Up to 1 year post-transplant

Title

Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy

Time Frame

Up to 150 days post-transplant

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Joseph

Phone

646-754-7398

Rachel.Joseph@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naamit Gerber, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Joseph

Phone

646-754-7398

Rachel.Joseph@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Naamit Gerber, MD

First Name & Middle Initial & Last Name & Degree

David Barbee, PhD

First Name & Middle Initial & Last Name & Degree

Jose Teruel

First Name & Middle Initial & Last Name & Degree

Christine Hitchen

First Name & Middle Initial & Last Name & Degree

Martha Malin, PhD

First Name & Middle Initial & Last Name & Degree

K. Sunshine Osterman, PhD

First Name & Middle Initial & Last Name & Degree

Paulina Galavis, PhD

First Name & Middle Initial & Last Name & Degree

Samir Al-Homsi, MD, MBA

First Name & Middle Initial & Last Name & Degree

Mohammad Abdul Hay, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

IPD Sharing 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.

IPD Sharing 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.

Learn more about this trial

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

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