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The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).
This study is a prospective phase II non-inferiority study investigating tocilizumab as a potential alternative to anti-thymocyte globulin (ATG) in haplo-cord transplantation. It is a single-center study based at Weill Cornell Medicine/NewYork Presbyterian Hospital.
The hypothesis is that tocilizumab is a safe and effective alternative to ATG in haplo-cord transplantation, facilitating transient engraftment of the haplo-identical stem cell graft without prolonged neutropenia or second nadir prior to durable cord engraftment while also preventing graft versus host disease (GVHD).
This study plans to enroll patients with hematologic malignancies in need of alternate donor transplant. All subjects will be conditioned with fludarabine, melphalan and total body irradiation (TBI), followed by a single dose of tocilizumab 8 mg/kg on Day -1. Patients will be enrolled into 4 successive cohorts, initially administering the current standard 3 doses of ATG 1.5 mg/kg (total 4.5 mg/kg). In the absence of safety signals, we will drop one dose of ATG in successive cohorts until the drug ultimately has been eliminated.
The primary endpoint of the study is successful haplo-derived neutrophil engraftment. Treatment will only be of interest if there is evidence that this rate is greater than 60%. If there are 4 or fewer successes, that dose group will be deemed unacceptable and the next higher ATG dose for which there were 5 or more success will be expanded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG Group I | Experimental | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
|
|
| ATG Group II | Experimental | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
|
|
| ATG Group III | Experimental | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment | This is defined as:
| 21 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Time elapsed between Day 0 and progression of the underlying malignancy for which the transplant was performed, assessed up to 5 years post-transplant. | 5 years post-transplant |
| Overall Survival |
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Inclusion Criteria:
Subject must have a confirmed diagnosis of one of the following:
Age ≥ 18 years.
Likely to benefit from allogeneic transplant in the opinion of the transplant physician.
An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.
Karnofsky Performance Status (KPS) of ≥ 70%.
Acceptable organ function as defined below:
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Gomez Arteaga, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ATG Group I | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2022 |
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|
| ATG Group IV | Experimental |
|
|
|
| Fludarabine | Drug | Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. |
|
|
| Melphalan | Drug | Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. |
|
|
| Anti-thymocyte globulin (rabbit) | Drug | Anti-thymocyte globulin (ATG) 1.5 mg/kg |
|
|
| Total Body Irradiation | Radiation | Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
|
Time elapsed between Day 0 and death from any cause, assessed up to 5 years post-transplant.
| 5 years post-transplant |
| Transplant-Related Mortality | Proportion of deaths which cannot be explained by persistence, relapse or progression of the underlying malignancy once the preparative regimen starts, assessed up to 5 years post-transplant. | 5 years post-transplant |
| Proportion of Platelet Engraftment Success | Proportion of patients who successfully achieve platelet engraftment, defined as a platelet count of >20k/microL for three consecutive days without transfusion support for seven consecutive days. | 6 months post-transplant |
| Proportion of Failure of the Haplo-Graft | Proportion of patients with a failed haplo-graft, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation (second nadir) | 21 days post-transplant |
| Proportion of Acute Graft-versus-Host Disease | Proportion of patients who develop acute graft-versus-host disease | 1 year post-transplant |
| Percentage of Chronic Graft-versus-Host Disease | Percentage of patients who develop chronic graft-versus-host disease | 5 years post-transplant |
| FG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| FG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| FG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| COMPLETED |
|
| NOT COMPLETED |
|
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | ATG Group I | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| BG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| BG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| BG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Primary Malignancy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment | This is defined as:
| No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort. | Posted | Number | percentage of participants | 21 days post-transplant |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Time elapsed between Day 0 and progression of the underlying malignancy for which the transplant was performed, assessed up to 5 years post-transplant. | Not Posted | 5 years post-transplant | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time elapsed between Day 0 and death from any cause, assessed up to 5 years post-transplant. | Not Posted | 5 years post-transplant | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Transplant-Related Mortality | Proportion of deaths which cannot be explained by persistence, relapse or progression of the underlying malignancy once the preparative regimen starts, assessed up to 5 years post-transplant. | Not Posted | 5 years post-transplant | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Platelet Engraftment Success | Proportion of patients who successfully achieve platelet engraftment, defined as a platelet count of >20k/microL for three consecutive days without transfusion support for seven consecutive days. | No subjects were enrolled to ATG Group IV, study enrollment was stopped before accrual reached that cohort. | Posted | Count of Participants | Participants | 6 months post-transplant |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Failure of the Haplo-Graft | Proportion of patients with a failed haplo-graft, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation (second nadir) | No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort. | Posted | Count of Participants | Participants | 21 days post-transplant |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Acute Graft-versus-Host Disease | Proportion of patients who develop acute graft-versus-host disease | No subjects were enrolled to ATG Group IV, study enrollment was stopped before accrual reached that cohort. | Posted | Count of Participants | Participants | 1 year post-transplant |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Chronic Graft-versus-Host Disease | Percentage of patients who develop chronic graft-versus-host disease | Not Posted | 5 years post-transplant | Participants |
All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATG Group I | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen | 5 | 10 | 8 | 10 | 10 | 10 |
| EG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen | 1 | 10 | 9 | 10 | 10 | 10 |
| EG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen | 1 | 1 | 1 | 1 | 1 | 1 |
| EG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Graft-versus-Host Disease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Hemophagocytic lymphohistiocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Colitis - Cytomegalovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Delayed Engraftment | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Failure to Thrive | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypovolemic shock | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemolytic Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Herpes simplex Reactivation | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lung Infection - COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Lung Infection -Chlamydia trachomatis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pancreatic Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Septic Shock | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Sinusoidal Obstruction Syndrome | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Throat Pain | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Coronavirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Human Metapneumovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Parainfluenza | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Viremia - Cytomegalovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Graft-versus-Host Disease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Viremia - Adenovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Adenovirus Colitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Parainfluenza | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Rhinovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Coronavirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Viremia - Cytomegalovirus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Respiratory Syncytial Virus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Hemolytic Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Infectious Colitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Candida pharyngitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| BK Virus Cystitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Gomez Arteaga, MD | Weill Cornell Medicine | 646-962-7950 | alg9117@med.cornell.edu |
| Sep 25, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| 30-39 years |
|
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Myelodysplastic Syndrome |
|
| Myeloproliferative Neoplasm |
|
| Non-Hodgkin Lymphoma |
|
| Other Acute Leukemia |
|
| OG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
|
|
| OG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
|
|
| OG001 | ATG Group II | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG002 | ATG Group III | Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
| OG003 | ATG Group IV |
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen. Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen. Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen |
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