Trial Outcomes & Findings for Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation (NCT NCT02259348)

Last Updated: 2017-05-30

Results Overview

To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm\^3 with evidence of donor cell engraftment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Day 42 post transplantation

Results posted on

2017-05-30

Participant Flow

Twelve participants meeting eligibility criteria were enrolled at St. Jude Children's Research Hospital between November 2014 and February 2015.

Six enrolled participants were blood donors and did not undergo transplantation.

Participant milestones

Participant milestones
Measure	Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Overall Study STARTED	12
Overall Study One Year Post-transplant	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Overall Study Donors	6
Overall Study Death	4

Baseline Characteristics

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Age, Continuous	12.6 years STANDARD_DEVIATION 5.5 • n=5 Participants
Age, Customized Age, Median	12.2 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Not otherwise specified Spanish, Hispanic, Latino	1 participants n=5 Participants
Race/Ethnicity, Customized Non Spanish speaking, Non Hispanic	5 participants n=5 Participants
Primary Diagnosis AML with 11q23/MLL abnormalities	2 participants n=5 Participants
Primary Diagnosis AML, multilineage dysplasia with prior MDS	1 participants n=5 Participants
Primary Diagnosis AML, not otherwise specified	2 participants n=5 Participants
Primary Diagnosis AML, without maturation	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 42 post transplantation

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Percentage of Participants Engrafted by Day 42 Post-transplant	100 percentage of participants

SECONDARY outcome

Timeframe: one year post transplantation

The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Incidence of Malignant Relapse	2 participants

SECONDARY outcome

Timeframe: one year post transplantation

The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Event-free Survival (EFS)	2 participants

SECONDARY outcome

Timeframe: one year post transplantation

The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Overall Survival (OS)	2 participants

SECONDARY outcome

Timeframe: 100 days post transplantation

Population: Two of six participants did not experience any acute GvHD.

The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Incidence and Severity of Acute GvHD Grade I	0 participants
Incidence and Severity of Acute GvHD Grade II	0 participants
Incidence and Severity of Acute GvHD Grade IV	1 participants
Incidence and Severity of Acute GvHD Grade III	3 participants

SECONDARY outcome

Timeframe: one year post transplantation

The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring." The number of participants with incidence by severity is given.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Incidence and Severity of Chronic GvHD Mild	0 participants
Incidence and Severity of Chronic GvHD Moderate	0 participants
Incidence and Severity of Chronic GvHD Severe	0 participants

SECONDARY outcome

Timeframe: 100 days post transplantation

Population: All six participants who received the protocol-defined treatment were evaluable for this analysis. One participant died of a non-transplant related cause (leukemia) prior to day 100. Although this participant did not complete the study to Day 100 post-transplantation, they were still evaluable for TRM.

The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the competing risk events.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Rate of Transplant-related Mortality (TRM)	0 participants

POST_HOC outcome

Timeframe: Day 42 post transplantation

ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm\^3 with evidence of donor cell engraftment.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Mean of Days to Absolute Neutrophil Count (ANC) Engraftment	10.3 days Standard Deviation 1.03

POST_HOC outcome

Timeframe: Day 42 post transplantation

ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm\^3 with evidence of donor cell engraftment.

Outcome measures

Outcome measures
Measure	Participants n=6 Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Median Days to Absolute Neutrophil Count (ANC) Engraftment	10 days Interval 9.0 to 12.0

Adverse Events

Participants

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants n=6 participants at risk Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Blood and lymphatic system disorders Hemorrhage, pulmonary	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Hepatobiliary disorders Hepatic failure (disorder)	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, candida glabrata, GI tract	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, culture negative, sepsis	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, enterococcus faecalis, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, escherichia coli, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, klebsiella oxytoca, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, pseudomonas aeruginosa, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, staphylococcus epidermidis, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, toxoplasmosis, cerebrospinal fluid	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Septic shock	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Nervous system disorders Seizure	33.3% 2/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Cryptogenic organizing pneumonia	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Failure, pulmonary	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure (disorder)	33.3% 2/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Renal and urinary disorders Failure, renal	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).

Other adverse events

Other adverse events
Measure	Participants n=6 participants at risk Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
Cardiac disorders Hypertension	33.3% 2/6 • Number of events 4 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Cardiac disorders Hypotension	50.0% 3/6 • Number of events 7 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Cardiac disorders Left ventricular systolic dysfunction	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Gastrointestinal disorders Mucositis	66.7% 4/6 • Number of events 4 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Gastrointestinal disorders Pneumatosis	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Blood and lymphatic system disorders Epistaxis	33.3% 2/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Gastrointestinal disorders Hemorrhage, gastrointestinal	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Abscess, mouth	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Febrile neutropenia	83.3% 5/6 • Number of events 10 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, adenovirus, respiratory tract	33.3% 2/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, adenovirus, stool	50.0% 3/6 • Number of events 7 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, BK virus, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, BK virus, urine	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, candida albicans, oral mucosa	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, candida albicans, tracheostomy site	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, candida guilliermondii, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, candida lusitaniae, small intestine	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, clostridium difficile, stool	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, coagulase negative staphylococcus, pleural fluid	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, disseminated fungus, organism unknown	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, enterobacter cloacae, trachael aspirate	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, human herpes virus 6, blood	50.0% 3/6 • Number of events 3 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, rotavirus, stool	50.0% 3/6 • Number of events 3 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, staphylococcus epidermidis, blood	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Infection, upper respiratory	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Infections and infestations Sinusitis	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Nervous system disorders Hallucinations (finding)	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Nervous system disorders Involuntary movement (finding)	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Nervous system disorders Seizure	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Bronchiolitis obliterans organizing pneumonia (disorder)	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	50.0% 3/6 • Number of events 3 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Infiltrates, pulmonary	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	16.7% 1/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Renal and urinary disorders Acute renal failure	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
Renal and urinary disorders Failure, renal	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Acute infusion reaction, boost	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Acute infusion reaction, granulocyte	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Acute infusion reaciton, NK cells	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Acute infusion reaction, stem cells	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Cytokine release syndrome, ATG	50.0% 3/6 • Number of events 3 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Engraftment syndrome	33.3% 2/6 • Number of events 2 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Systemic inflammatory response syndrome (disorder)	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).
General disorders Tumor lysis syndrome	16.7% 1/6 • Number of events 1 • Adverse events were collected from study enrollment through off-study date (up to 16 months).

Additional Information

Brandon M. Triplett, MD

St. Jude Children's Research Hospital

Phone: 901-595-2766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place