Trial Outcomes & Findings for T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant (NCT NCT01621477)

Last Updated: 2017-02-20

Results Overview

Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

One year post transplant

Results posted on

2017-02-20

Participant Flow

Thirty four participants were enrolled at St. Jude Children's Research Hospital between August 2012 and November 2014.

Of the 34 participants enrolled on the study, 17 were donors. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.

Participant milestones

Participant milestones
Measure	Treatment Study participants (excluding donors) who were enrolled and underwent transplant.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
Age, Continuous	6.97 years n=5 Participants
Gender Female	9 Participants n=5 Participants
Gender Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year post transplant

Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
One-year Survival (OS)	7 participants

SECONDARY outcome

Timeframe: One year post transplantation.

Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Incidence of Malignant Relapse	10 participants

SECONDARY outcome

Timeframe: one year post transplant

Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Event-Free Survival (EFS)	4 participants

SECONDARY outcome

Timeframe: one year post transplant

Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Disease-Free Survival (DFS)	7 participants

SECONDARY outcome

Timeframe: 100 days post transplant

The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Incidence and Severity of Acute Graft Versus Host Disease (GVHD) No Acute GVHD	9 participants
Incidence and Severity of Acute Graft Versus Host Disease (GVHD) Grade I	3 participants
Incidence and Severity of Acute Graft Versus Host Disease (GVHD) Grade II	1 participants
Incidence and Severity of Acute Graft Versus Host Disease (GVHD) Grade III	3 participants
Incidence and Severity of Acute Graft Versus Host Disease (GVHD) Grade IV	1 participants

SECONDARY outcome

Timeframe: 100 days post transplant

The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD) Severe	0 participants
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD) No Chronic GVHD	15 participants
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD) Mild	0 participants
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD) Moderate	2 participants

SECONDARY outcome

Timeframe: 100 days post transplant

The number of participants who died due to TRM in the first 100 days post-transplant is given.

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants Study participants (excluding donors) who were enrolled and underwent transplant.
Number of Participants With Transplant Related Mortality (TRM)	2 participants

Adverse Events

Treatment

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=17 participants at risk Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
Immune system disorders Allergic reaction, dexmedetomidine (precedex)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Blood and lymphatic system disorders Graft failure	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Hypotension	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Pericardial effusion	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Blood and lymphatic system disorders Thrombotic microangiopathy (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Fever without neutropenia	29.4% 5/17 • Number of events 6 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Gastrointestinal disorders Stomatitis, viral	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Blood and lymphatic system disorders Hemorrhage, pulmonary	17.6% 3/17 • Number of events 3 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Hepatobiliary disorders Hepatitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Febrile neutropenia	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, enterobacter cloacae, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, pseudomonas aeruginosa, disseminated	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, staphylococcus epidermidis, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Pneumonia	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Apnea	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Mood alteration	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Seizure	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Subdural hygroma	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Uremic encephalopathy (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome (disorder	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Hypoxia	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Interstitial pneumonitis syndrome	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Nodule, pulmonary lobe of lung, right	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Respiratory failure (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Tension pneumothorax, lung, right	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Renal and urinary disorders Failure, renal	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Acute infusion reaction, stem cells	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Engraftment syndrome	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).

Other adverse events

Other adverse events
Measure	Treatment n=17 participants at risk Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
Immune system disorders Allergic drug reaction, cefepime	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Immune system disorders Allergic drug reaction, vancomycin	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Bradycardia (finding)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Cardiomyopathy	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Heart failure (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Hypertension	35.3% 6/17 • Number of events 7 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Hypotension	17.6% 3/17 • Number of events 4 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Pericardial effusion	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Cardiac disorders Pulmonary hypertension	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Fever without neutropenia	23.5% 4/17 • Number of events 4 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Skin and subcutaneous tissue disorders Neutrophilic dermatosis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Gastrointestinal disorders Enteritis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Gastrointestinal disorders Ileus	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Gastrointestinal disorders Mucositis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Gastrointestinal disorders Pneumatosis intestinalis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Blood and lymphatic system disorders Hemorrhagic cystitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Hepatobiliary disorders Cholecystitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Hepatobiliary disorders Cholelithiasis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Hepatobiliary disorders Colitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Hepatobiliary disorders Veno-occlusive disease, hepatic	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Candidiasis, oral	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Encephalitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Febrile neutropeenia	88.2% 15/17 • Number of events 25 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Hepatitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, adenovirus, respiratory tract	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, adenovirus, stool	58.8% 10/17 • Number of events 12 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, BK virus, blood	29.4% 5/17 • Number of events 5 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, BK virus, urine	23.5% 4/17 • Number of events 4 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, candida parapsilosis, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, coagulase negative staphylococcus, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, enterococcus faecalis, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, Epstein Barr virus, blood	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, human herpes virus 6, blood	29.4% 5/17 • Number of events 6 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, klebsiella, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, lactobacillus, urinary tract	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, microbacterium aurum, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, parainfluenza type 4, respiratory tract	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, respiratory syncytial virus, respiratory tract	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, rotavirus, stool	5.9% 1/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, staphylococcus epidermidis, blood	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, staphylococcus, urine	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, vancomycin resistant enterococcus faecium, stool	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, vancomycin-resistant enterococcus, blood	11.8% 2/17 • Number of events 3 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Infection, vancomycin resistant enterococcus, rectum	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Pneumonia	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Reactivation, Epstein Barr virus	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Infections and infestations Sinusitis	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Metabolism and nutrition disorders Hemophagocytic lymphohistiocytosis (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Metabolism and nutrition disorders Hypocalcemia (disorder)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Encephalopathy	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Obstructive sleep apnea	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Seizure	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Nervous system disorders Sensory neuropathy	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Pain, knee, bilateral	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Pain, shoulder, bilateral	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Hypoxia	17.6% 3/17 • Number of events 3 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Pleural effusion, bilateral	11.8% 2/17 • Number of events 2 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Respiratory, thoracic and mediastinal disorders Pleural effusion, right	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Renal and urinary disorders Cystitis	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Renal and urinary disorders Hemorrhagic cystitis	29.4% 5/17 • Number of events 5 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Acute infusion reaction, NK cells	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Acute infusion reaction, stem cells	82.4% 14/17 • Number of events 16 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Immune system disorders Cytokine release syndrome, ATG	70.6% 12/17 • Number of events 12 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
General disorders Engraftment syndrome	29.4% 5/17 • Number of events 5 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Vascular disorders Occlusive thrombus (morphologic abnormality)	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
Vascular disorders Thrombus, upper extremity and neck, left	5.9% 1/17 • Number of events 1 • Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).

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