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| ID | Type | Description | Link |
|---|---|---|---|
| HM20005586 | Other Identifier | VCU Office of Research Subjects Protection |
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| Name | Class |
|---|---|
| Massey Cancer Center | OTHER |
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Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients receiving the investigational regimen.This is a randomized phase II clinical trial, comparing two different dosing schedules of mycophenolate mofetil for graft versus host disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study arms will be performed based on T cell counts at day 60.
In this study, the investigators will utilize a regimen combining low dose total body irradiation and rabbit ATG to facilitate stem cell transplantation (SCT) with human leukocyte antigen (HLA) matched related and unrelated donors. Based on the hypothesis that early treatment interventions have significant late effects in allogeneic SCT, a simple intervention, varying the duration of intense immunosuppression following SCT, will be investigated in this study. This may allow more robust recovery of donor immune system cells in the first two months following transplantation and eventually result in lower risk of cancer relapse, while maintaining effective graft versus host disease (GVHD) control. Patients will be randomly assigned to receive GVHD prevention therapy using one of two different immunosuppressive regimens with tacrolimus & mycophenolate mofetil (MMF). Patients assigned to the investigational group will receive MMF for 15 days following SCT with growth factor support using granulocyte macrophage colony stimulating factor (GM-CSF) beginning on post-transplant day 4. Patients randomized to the standard treatment group will receive MMF for 30 days following SCT with cytokine support using granulocyte colony stimulating factor (G-CSF) beginning on post-transplant day 4. If one of these treatment groups demonstrates an improvement in donor immune cell recovery, there may be a slow increase in the likelihood of patients being assigned to that more successful treatment group. Eventually the two groups will be compared with respect to the likelihood of either relapse or GVHD developing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (MMF-15, sargramostim) | Experimental | Patients receive mycophenolate mofetil (MMF) PO or IV twice daily (BID) on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. |
|
| Arm II (MMF-30, filgrastim) | Active Comparator | Patients receive mycophenolate mofetil PO or IV (twice daily) BID on days 0-30 and filgrastim G-CSF from post-transplant day 4 until neutrophil engraftment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug | Given PO, by mouth, orally or IV, intravenous medication administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI. | Up to 2 years following stem cell transplant |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Day 60 Donor-derived (dd) Cluster of Differentiation (CD)3 10E3per microL Counts. | Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL. | 60 Days Following Stem Cell Transplant |
Not provided
Inclusion Criteria
Any of the following high risk or recurrent hematological malignancies:
Hodgkin lymphoma (HL)
Non-Hodgkin lymphoma (NHL)
Chronic lymphocytic leukemia (CLL)
Multiple myeloma (MM)
Acute myelogenous leukemia (AML)
Acute lymphocytic leukemia (ALL)
Chronic myelogenous leukemia (CML)
Myelodysplastic syndrome (MDS)
*Note: Determination that the malignancy is high risk will be made by the investigator.
Investigator determination that the patient is an appropriate candidate for reduced intensity allogeneic SCT with the standard Massey Cancer Center-Virginia Commonwealth Health System Bone Marrow Transplant Massey Cancer Center Virginia Commonwealth University Health System Bone Marrow Transplant (MCC-VCUHS BMT) Program regimen employed in this trial
Patients with or without previous myeloablative autologous transplant
HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
*Note: Unrelated donors must be matched at HLA-A, -B, -C, and -DRB1 loci. However, a single locus mismatch will be acceptable in the event a more closely matched donor is not available.
Age ≥ 40 to < 75 years; patients 18 to 39 years of age will be eligible only if the investigator has determined that the patient has comorbidity(ies) precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
Karnofsky Performance Status of 70-100%
Negative serology for HIV
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines
Ability to understand and the willingness to sign a written informed consent document *Note: The consent form must be signed and dated prior to initiation of SCT preparative treatments.
Exclusion Criteria
Previous therapeutic radiation therapy (RT) that exceeds critical structure tolerance doses as determined by a radiation oncologist
Uncontrolled viral, fungal, or bacterial infection
Active meningeal or central nervous system disease
Previous therapy with rabbit anti-thymocyte globulin (ATG); previous treatment with equine ATG is allowed if more than 3 months ago
*Note: Previous myeloablative autologous transplant is permitted but not required.
Pregnancy or breastfeeding
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Amir A Toor, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (MMF-15, Sargramostim) | Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF. |
| 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 | Nov 24, 2021 |
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Not provided
|
| Sargramostim | Biological | GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF. |
|
|
| Filgrastim | Biological | G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. |
|
|
| The Probability of Overall Survival (OS) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) |
Overall survival (days to event or survival: time-to-event; survival: categorical) |
| Randomization up to 2 years |
| Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Acute Graft Vs Host Disease (GVHD) | The number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | 60 Days following stem cell transplant |
| Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD) | The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | 60 Days following stem cell transplant |
| Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections | The number of patients diagnosed with an opportunistic infections. | 60 Days following stem cell transplant |
| Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss. | Number of patients with engraftment loss. | 60 Days Following Stem Cell Transplant |
| Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)Diagnosed With Differences in the Rates of Engraftment Syndrome. | Number of patients diagnosed with engraftment syndrome. | 60 Days Following Stem Cell Transplant |
| Differences in the Rates of Achieving Donor Chimerisms (the Percentage of DNA in the Sample Which Comes From the Donor) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of patients that achieved donor chimerisms by day 100. | 100 Days following Stem Cell Transplant |
| Differences in the Rates of T-cell Recovery Kinetics Following Stem Cell Transplantation (SCT) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT. | 100 Days Following Stem Cell Transplantation |
| FG001 | Arm II (MMF-30, Filgrastim) | Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim G-CSF from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (MMF-15, Sargramostim) | Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF. |
| BG001 | Arm II (MMF-30, Filgrastim) | Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim GCSF from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. |
| BG002 | 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, 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 | 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 | The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI. | Posted | Count of Participants | Participants | Up to 2 years following stem cell transplant |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Difference Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Day 60 Donor-derived (dd) Cluster of Differentiation (CD)3 10E3per microL Counts. | Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL. | Posted | Mean | Standard Error | 10^3 *cells* per microliter | 60 Days Following Stem Cell Transplant |
| |||||||||||||||||||||||||||||||||
| Secondary | The Probability of Overall Survival (OS) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) | Overall survival (days to event or survival: time-to-event; survival: categorical) | Posted | Number | Probablility of 2 year survival | Randomization up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Acute Graft Vs Host Disease (GVHD) | The number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | Posted | Count of Participants | Participants | 60 Days following stem cell transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD) | The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | Posted | Count of Participants | Participants | 60 Days following stem cell transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections | The number of patients diagnosed with an opportunistic infections. | Posted | Count of Participants | Participants | 60 Days following stem cell transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss. | Number of patients with engraftment loss. | Posted | Count of Participants | Participants | 60 Days Following Stem Cell Transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)Diagnosed With Differences in the Rates of Engraftment Syndrome. | Number of patients diagnosed with engraftment syndrome. | Posted | Count of Participants | Participants | 60 Days Following Stem Cell Transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences in the Rates of Achieving Donor Chimerisms (the Percentage of DNA in the Sample Which Comes From the Donor) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of patients that achieved donor chimerisms by day 100. | Posted | Count of Participants | Participants | 100 Days following Stem Cell Transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Differences in the Rates of T-cell Recovery Kinetics Following Stem Cell Transplantation (SCT) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT. | Posted | Mean | Standard Deviation | 10^3 *cells* per microliter | 100 Days Following Stem Cell Transplantation |
|
All Cause Mortality assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months.
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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 | Arm I (MMF-15, Sargramostim) | Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF. | 4 | 15 | 15 | 15 | 15 | 15 |
| EG001 | Arm II (MMF-30, Filgrastim) | Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. | 6 | 11 | 11 | 11 | 10 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| cardiac disorders, other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| surgical and medical procedures, other | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine Aminotransferase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colonic Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Entercolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ileal Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Small Intestine Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CD4 Lymphocytes Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrilation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter Related Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amir Toor, Principal Investigator | Virginia Commonwealth University Massey Cancer Center | 804 828 5116 | amir.toor@vcuhealth.org |
| Aug 8, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 24, 2021 | Aug 8, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D007945 | Leukemia, Lymphoid |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D054219 | Neoplasms, Plasma Cell |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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 |
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| Unknown or Not Reported |
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