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The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in complete remission (CR).
This open label two-step phase II study is designed to determine the safety and efficacy of epigenetic priming with 5-Azacytidine immediately prior to reduced intensity conditioning for an in vivo T-cell depleted hematopoietic stem cell transplantation for high risk myeloid malignancies in complete remission (CR).
Subjects will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine, melphalan and total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated Human Leukocyte Antigen (HLA) matched donor.
The effect of 5-azacytidine on global gene methylation will be assessed. Evaluations for safety, in particular for graft failure, transplant related mortality and acute graft versus host disease will be made on a weekly basis. Efficacy, as defined by disease free survival, will be evaluated with a bone marrow biopsy at the standard time points, which are one-, three-, six-, and twelve-months after transplant and upon clinical suspicion within regular follow-up visits - weekly for the first 3 months, then biweekly for 3 months, then monthly until one-year post-stem cell transplant. Thereafter, unless otherwise dictated by the clinical scenario, the follow up visits will be every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Azacytidine | Experimental | Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Azacytidine | Drug | Patients will be given a five day course of subcutaneous 5-azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival at 1 Year Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 1 year post-transplant. | 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival at 6 Months Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 6 months post-transplant | 6 months post-transplant |
| Disease Free Survival at 2 Years Post-transplant |
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Inclusion Criteria:
Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) as specified below:
Life expectancy not severely limited by concomitant disease
Karnofsky Performance Score greater than or equal to 70%.
Adequate organ function as defined below:
Serum Bilirubin:<2.0 mg/dL; Alanine Aminotransferase (ALT) (SGPT): <3 x upper limit of normal; Creatinine Clearance:>60 mL/min (eGFR as estimated by the modified Modification of Diet in Renal Disease Study (MDRD) equation)
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Mayer, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 Azacytidine | Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible. Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3. Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3. Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors. TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3). |
| 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 | Apr 16, 2018 |
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|
|
| Fludarabine | Drug | Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3. |
|
|
| Melphalan | Drug | Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Melphalan will be given at 140 mg/m2 IV on day -3. |
|
|
| Alemtuzumab | Drug | Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors. |
|
|
| Total Body Irradiation | Radiation | Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Total Body Irradiation (TBI) will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3). |
|
|
Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 2 years post-transplant. |
| 2 years post-transplant |
| Overall Survival at 6 Months Post-transplant | Number of participants alive at 6 months post-transplant | 6 months post-transplant |
| Overall Survival at 1 Year Post-Transplant | Number of participants alive at 1 year post-transplant | 1 year post-transplant |
| Overall Survival at 2 Years Post-Transplant | Number of participants alive at 2 years post-transplant | 2 years post-transplant |
| Graft Failure | Number of patients who experience graft failure, 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. | 21 days post-transplant |
| Acute Graft-versus-Host Disease (GVHD) | Number of patients who develop acute graft-versus-host disease of any grade. | 2 years post-transplant |
| High-Risk Extensive Chronic Graft-versus-Host-Disease | Number of patients who develop high-risk extensive chronic graft-versus-host disease. Extensive chronic GVHD is defined as generalized skin or multiple organ involvement. High risk chronic GVHD is defined as platelet count of less than 100k/microL | 2 years post-transplant |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 Azacytidine | Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible. Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3. Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3. Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors. TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 |
| ||||||||||||||||||
| Disease | Hematologic malignancy that allogeneic hematopoietic stem cell transplant is intended to treat | Count of Participants | Participants |
| |||||||||||||||||
| Donor Relationship | Donor relationship to participant for allogeneic stem cell transplant | One participant was removed from the study before stem cell transplantation and is therefore unevaluable for this baseline measure | 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 | Disease Free Survival at 1 Year Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 1 year post-transplant. | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 1 year post-transplant |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival at 6 Months Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 6 months post-transplant | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 6 months post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival at 2 Years Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 2 years post-transplant. | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 2 years post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 6 Months Post-transplant | Number of participants alive at 6 months post-transplant | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 6 months post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 1 Year Post-Transplant | Number of participants alive at 1 year post-transplant | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant | Posted | Count of Participants | Participants | 1 year post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 2 Years Post-Transplant | Number of participants alive at 2 years post-transplant | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 2 years post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Graft Failure | Number of patients who experience graft failure, 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. | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 21 days post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Graft-versus-Host Disease (GVHD) | Number of patients who develop acute graft-versus-host disease of any grade. | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 2 years post-transplant |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | High-Risk Extensive Chronic Graft-versus-Host-Disease | Number of patients who develop high-risk extensive chronic graft-versus-host disease. Extensive chronic GVHD is defined as generalized skin or multiple organ involvement. High risk chronic GVHD is defined as platelet count of less than 100k/microL | 1 participant was unevaluable as they were removed from study before undergoing hematopoietic stem cell transplant. | Posted | Count of Participants | Participants | 2 years post-transplant |
|
Adverse events were collected for all patients from start of 5-azacytidine therapy through 5 years post-transplant or when the participant was removed from the study, whichever was sooner.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. Per protocol, events reported were all infectious events and Grade 3 and higher events for non-infectious events
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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 | 5 Azacytidine | Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible. Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3. Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3. Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors. TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3). | 28 | 40 | 28 | 40 | 38 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atypical Hemolytic Uremic Syndrome | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lower Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intra-Abdominal Abscess | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Failure to Thrive | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypervolemia | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion-Related Reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Human Herpesvirus 6 Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Norovirus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Influenza B | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Rhinovirus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Herpes Simplex Virus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Graft-versus-Host Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic Graft-versus-Host Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Post-Transplant Lymphoproliferative Disorder | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial Hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Posterior Reversible Encephalopathy Syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Periapical Abscess | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatosplenic Lesion | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Parainfluenza | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Clostridium difficile Colitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Human Herpesvirus 6 Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Respiratory Synctyial Virus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Varicella Zoster Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Influenza B | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Rhinovirus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| BK Virus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Human metapneumovirus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Staphylococcus aureus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infectious Diarrhea | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Influenza A | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - SARS-CoV-2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Coronavirus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Central Line Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Epstein Barr Virus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Graft-versus-Host Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic Graft-versus-Host Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Mayer, MD | Weill Cornell Medical College | 646-962-7950 | sam2033@med.cornell.edu |
| Aug 20, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004915 | Leukemia, Erythroblastic, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D000074323 | Alemtuzumab |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Myelodysplastic Syndrome/Myeloproliferative Disease |
|
| Matched Unrelated Donor |
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| Participants |
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| Participants |
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| Participants |
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