Trial Outcomes & Findings for A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT (NCT NCT04509765)
NCT ID: NCT04509765
Last Updated: 2026-05-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Up to 1 year post-transplant
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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36
|
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Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
|
Overall Study
Treatment denied by insurance
|
1
|
|
Overall Study
Disease recurrence
|
1
|
|
Overall Study
BM donor did not commit
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1
|
Baseline Characteristics
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
Baseline characteristics by cohort
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Age, Continuous
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37 Years
n=54 Participants
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Sex: Female, Male
Female
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18 Participants
n=54 Participants
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Sex: Female, Male
Male
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15 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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16 Participants
n=54 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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17 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
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7 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
|
Region of Enrollment
United States
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33 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post-transplantPopulation: Patients who received total body irradiation
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.
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung
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33 Participants
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SECONDARY outcome
Timeframe: Up to 1 year post-transplantPopulation: 30 participants were failure free; 3 participants died within the time frame and are included in the analysis below
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.
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=3 Participants
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).
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|---|---|
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Event Free Survival (EFS)
|
86 Days Post-Transplant
Interval 74.0 to 169.0
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SECONDARY outcome
Timeframe: Up to 150 days post-transplantPopulation: Patients who received total body irradiation
Number of participants with Maximum dose to 2cc of the entire body (D2cc) \<130% of Rx dose
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose.
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26 Participants
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SECONDARY outcome
Timeframe: Up to 100 Days Post-TransplantPopulation: Patients who received total body irradiation
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
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome
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0 Participants
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SECONDARY outcome
Timeframe: Up to 150 days post-transplantPopulation: Patients who received total body irradiation
Number of participants with Maximum dose to 0.03cc of organs at risk \<120% of Rx dose
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose.
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33 Participants
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SECONDARY outcome
Timeframe: 100 days post-transplantPopulation: Patients who received total body irradiation
Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 150 days post-transplantPopulation: Patients who received total body irradiation
Number of participants with mean dose of \<11Gy (1100 cGy) to either kidney
Outcome measures
| Measure |
Patients With Hematologic Malgnancies
n=33 Participants
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).
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|---|---|
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Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy
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33 Participants
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Adverse Events
Patients With Hematologic Malgnancies
Serious events: 22 serious events
Other events: 19 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Patients With Hematologic Malgnancies
n=33 participants at risk
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).
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
|
3.0%
1/33 • 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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|
Investigations
Alanine Aminotransferase Increased
|
3.0%
1/33 • 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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|
Metabolism and nutrition disorders
Anorexia
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9.1%
3/33 • 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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|
Investigations
Aspartate Aminotransferase Increased
|
3.0%
1/33 • 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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|
Investigations
Blood Bilirubin Increased
|
9.1%
3/33 • 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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|
Gastrointestinal disorders
Colitis
|
3.0%
1/33 • 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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|
Nervous system disorders
Confusion
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
3.0%
1/33 • 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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|
Metabolism and nutrition disorders
Dehydration
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3.0%
1/33 • 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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|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • 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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|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.0%
1/33 • 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.
|
|
General disorders
Fever
|
27.3%
9/33 • 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.
|
|
General disorders
Flu Like Symptoms
|
3.0%
1/33 • 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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|
Nervous system disorders
Headache
|
3.0%
1/33 • 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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Investigations
Transaminitis
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • 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.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Lung Infection
|
6.1%
2/33 • 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.
|
|
Infections and infestations
Meningitis
|
3.0%
1/33 • 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.
|
|
General disorders
Multi-organ failure
|
3.0%
1/33 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
3.0%
1/33 • 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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.0%
1/33 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis and Bronchiolitis
|
3.0%
1/33 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
3.0%
1/33 • 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.
|
|
Psychiatric disorders
Suicide attempt
|
3.0%
1/33 • 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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Viremia
|
6.1%
2/33 • 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.
|
|
Infections and infestations
Upper respiratory infection
|
3.0%
1/33 • 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.
|
Other adverse events
| Measure |
Patients With Hematologic Malgnancies
n=33 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
1/33 • 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.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.0%
1/33 • 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.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.0%
1/33 • 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.
|
|
Investigations
Alkaline Phosphatase Increased
|
3.0%
1/33 • 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.
|
|
Gastrointestinal disorders
Anal Ulcer
|
3.0%
1/33 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • 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.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.1%
4/33 • 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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.1%
2/33 • 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.
|
|
Infections and infestations
Bacteremia
|
3.0%
1/33 • 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.
|
|
Gastrointestinal disorders
Bloating
|
3.0%
1/33 • 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.
|
|
Investigations
Blood Bilirubin Increased
|
12.1%
4/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
18.2%
6/33 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • 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.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • 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.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
3/33 • 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.
|
|
General disorders
Fever
|
3.0%
1/33 • 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.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • 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.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.0%
1/33 • 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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
2/33 • 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.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.0%
1/33 • 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.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Cytomegalovirus
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Infections and Infestations, Other
|
3.0%
1/33 • 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.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • 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.
|
|
General disorders
Pain
|
3.0%
1/33 • 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.
|
|
Investigations
Platelet count decreased
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33 • 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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.0%
1/33 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
1/33 • 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.
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
3.0%
1/33 • 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.
|
|
Infections and infestations
Viremia
|
3.0%
1/33 • 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.
|
|
Investigations
White blood cell decreased
|
3.0%
1/33 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place