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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-100601 | |||
| CDR0000667954 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Preparative Regimen:
Graft-vs-Host Disease (GVHD) Prophylaxis:
NOTE: * Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is < 50% at day 60 or patient has progressive disease.
Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological |
| ||
| donor lymphocytes |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method. | Duration of study (up to 5.5 years) |
| Comparison of EFS Distribution to That of CALGB-100002 | EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Complete response (CR) rate is reported as the percentage of participants who achieved a CR. | Up to 5.5 years |
| Overall Survival | Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic malignancies:
Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
Absolute lymphocytosis of > 5,000/μL
Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)
Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
Non-Hodgkin lymphoma
Hodgkin lymphoma
Multiple myeloma
Acute myeloid leukemia
Myelodysplastic syndrome (MDS)
Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
Healthy donor meeting one of the following criteria:
HLA-identical sibling (6/6)
8/8 matched-unrelated donor
No syngeneic donors
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States | ||
| CCOP - Christiana Care Health Services |
Not provided
Between May 2010 and March 2012, 6 participants were recruited.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| filgrastim | Biological |
|
| therapeutic allogeneic lymphocytes | Biological |
|
| busulfan | Drug |
|
| fludarabine phosphate | Drug |
|
| methotrexate | Drug |
|
| mycophenolate mofetil | Drug |
|
| tacrolimus | Drug |
|
| reduced-intensity transplant conditioning procedure | Other |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| Up to 5.5 years |
| Rate of Opportunistic Infections | Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant. | 1 year post transplant |
| Newark |
| Delaware |
| 19713 |
| United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Union Hospital of Cecil County | Elkton MD | Maryland | 21921 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Event-free Survival (EFS) | EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method. | Due to study termination, data were not collected and the outcome measure was not analyzed. | Posted | Duration of study (up to 5.5 years) |
|
| |||||||||||||||||||
| Primary | Comparison of EFS Distribution to That of CALGB-100002 | EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test. | Due to study termination, data were not collected and the outcome measure was not analyzed. | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Complete Response Rate | Complete response (CR) rate is reported as the percentage of participants who achieved a CR. | Due to study termination, data were not collected and the outcome measure was not analyzed. | Posted | Up to 5.5 years |
|
| |||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method. | Due to study termination, data were not collected and the outcome measure was not analyzed. | Posted | Up to 5.5 years |
|
| |||||||||||||||||||
| Secondary | Rate of Opportunistic Infections | Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant. | Due to study termination, data were not collected and the outcome measure was not analyzed. | Posted | 1 year post transplant |
|
|
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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 | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Flashing lights | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Death NOS | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Cholesterol high | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| GGT increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Genital edema | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | MedDRA 12 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia | abashey@bmtga.com |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D000013 | Congenital Abnormalities |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D015463 | Leukemia, Prolymphocytic |
| D015470 | Leukemia, Myeloid, Acute |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006689 | Hodgkin Disease |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D012008 | Recurrence |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D015473 | Leukemia, Promyelocytic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D016399 | Lymphoma, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000069585 | Filgrastim |
| D002066 | Busulfan |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| 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 |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|