Hematologic Malignancy
Conditions
Keywords
Myeloablative Treatment, Total Body Irradiation
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.
Interventions
RADIATIONLinac 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).
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 criteria
l 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung | 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): 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival (EFS) | 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. |
| 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 | Number of participants with Maximum dose to 2cc of the entire body (D2cc) \<130% of Rx dose |
| Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome | 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 |
| Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose. | Up to 150 days post-transplant | Number of participants with Maximum dose to 0.03cc of organs at risk \<120% of Rx dose |
| Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant | 100 days post-transplant | Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant |
| Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy | Up to 150 days post-transplant | Number of participants with mean dose of \<11Gy (1100 cGy) to either kidney |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNaamit Gerber, MD
NYU Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 33 |
| other Total, other adverse events | 19 / 33 |
| serious Total, serious adverse events | 22 / 33 |
Outcome results
None listed