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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01898 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97214 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution.
SECONDARY OBJECTIVES:
I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35.
After completion of study treatment, patients are followed up periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (stem cell transplant with GVHD prophylaxis) | Experimental | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludarabine phosphate | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Disease Free Survival Probability | The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute GvHD | Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval. | 12 months |
| Overall Survival | The survival function will be estimated and plotted using the method of Kaplan and Meier. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dianna S. Howard | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Stem Cell Transplant With GVHD Prophylaxis) | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation fludarabine phosphate: Given IV busulfan: Given IV cyclophosphamide: Given IV allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant tacrolimus mycophenolate mofetil |
| 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 | Mar 12, 2021 |
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| busulfan | Drug | Given IV |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Undergo myeloablative or reduced intensity allogeneic stem cell transplant |
|
| tacrolimus | Drug |
|
|
| mycophenolate mofetil | Drug |
|
|
| At 12 months |
| Progression Free Survival | Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year. | At 12 months |
| Relapse-free Mortality | Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk. | At 12 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Stem Cell Transplant With GVHD Prophylaxis) | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation fludarabine phosphate: Given IV busulfan: Given IV cyclophosphamide: Given IV allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant tacrolimus mycophenolate mofetil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were 18-69 years | Mean | Standard Deviation | years |
| ||||||||||||||||
| 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 |
|
| 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 | 12 Month Disease Free Survival Probability | The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier. | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Acute GvHD | Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | The survival function will be estimated and plotted using the method of Kaplan and Meier. | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year. | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Relapse-free Mortality | Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk. | Posted | Mean | 95% Confidence Interval | days | At 12 months |
|
|
Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
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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 | Treatment (Stem Cell Transplant With GVHD Prophylaxis) | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation fludarabine phosphate: Given IV busulfan: Given IV cyclophosphamide: Given IV allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant tacrolimus mycophenolate mofetil | 13 | 27 | 27 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Retinal vascular disorder | Eye disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Ongoing viremia | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Stenotrophomonas | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Renal hemorrhage | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| ALC decrease | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypervolemia | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Periocardial effusions | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 4.0 | Non-systematic Assessment | Asthenia, lethargy, malaise |
|
| Dry eye | Eye disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Oral mucositis | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Edema, face | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Edema, limbs | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| BK viruria urine | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| CMV Miremia | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| SKin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Nurse | Wake Forest Baptist Comprehensive Cancer Center | 336-716-4761 | krike@wakehealth.edu |
| Aug 14, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2021 | Aug 5, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|