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Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Hematologic Malgnancies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| Up to 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | 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. | 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. |
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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.
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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naamit Gerber, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Hematologic Malgnancies | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Hematologic Malgnancies | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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):
| Patients who received total body irradiation | Posted | Count of Participants | Participants | Up to 1 year post-transplant |
|
Non-serious AEs collected for up to 100 days post transplant; SAEs and all-cause mortality collected for up to 1 year post transplant
Systemic - Investigators assessed at each routine post-transplant office visit; participants were encouraged to call the study team and report any adverse events in-between routine office visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Hematologic Malgnancies | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naamit Kurshan Gerber, MD | NYU Langone Health | 212-731-5003 | Naamit.gerber@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Apr 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
Number of participants with 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 | 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 |
| Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose. | Number of participants with Maximum dose to 0.03cc of organs at risk <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 | Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant | 100 days post-transplant |
| Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy | Number of participants with mean dose of <11Gy (1100 cGy) to either kidney | Up to 150 days post-transplant |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Event Free Survival (EFS) | 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. | 30 participants were failure free; 3 participants died within the time frame and are included in the analysis below | Posted | Median | Full Range | Days Post-Transplant | Up to 1 year post-transplant |
|
|
|
| Secondary | Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose. | Number of participants with Maximum dose to 2cc of the entire body (D2cc) <130% of Rx dose | Patients who received total body irradiation | Posted | Count of Participants | Participants | Up to 150 days 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 | Patients who received total body irradiation | Posted | Count of Participants | Participants | Up to 100 Days Post-Transplant |
|
|
|
| Secondary | Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose. | Number of participants with Maximum dose to 0.03cc of organs at risk <120% of Rx dose | Patients who received total body irradiation | Posted | Count of Participants | Participants | Up to 150 days post-transplant |
|
|
|
| Secondary | Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant | Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant | Patients who received total body irradiation | Posted | Count of Participants | Participants | 100 days post-transplant |
|
|
|
| Secondary | Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy | Number of participants with mean dose of <11Gy (1100 cGy) to either kidney | Patients who received total body irradiation | Posted | Count of Participants | Participants | Up to 150 days post-transplant |
|
|
|
| 3 |
| 33 |
| 22 |
| 33 |
| 19 |
| 33 |
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Cytomegalovirus infection reactivation | Infections and infestations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flu Like Symptoms | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Transaminitis | Investigations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Intracranial Hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Lung Infection | Infections and infestations | Systematic Assessment |
|
| Meningitis | Infections and infestations | Systematic Assessment |
|
| Multi-organ failure | General disorders | Systematic Assessment |
|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchitis and Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Viremia | Infections and infestations | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
|
| Anal Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cytomegalovirus infection reactivation | Infections and infestations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cytomegalovirus | Infections and infestations | Systematic Assessment |
|
| Infections and Infestations, Other | Infections and infestations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | Systematic Assessment |
|
| Viremia | Infections and infestations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
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