Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| GENZ-WSU-2007-127 | |||
| 2007-127 | Other Identifier | Barbara Ann Karmanos Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor 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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Conditioning regimen: Patients receive 1 of 6 conditioning regimens (standard of care treatment) between days -9 and -3, based on diagnosis and the treating physician's preference regarding regimen intensity.
Allogeneic peripheral blood stem cell transplantation: Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
Graft-versus-host disease prophylaxis (GVHD): Patients receive tacrolimus IV continuously over 24 hours or orally and sirolimus orally beginning on day -3 and continuing until day 30 or day 90, followed by a taper in the absence of GVHD. Patients also receive anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
Blood samples are obtained at baseline and periodically during study for correlative biomarker studies. Samples are analyzed by T-cell immunophenotyping, absolute subset number quantification, and multi-parameter flow cytometry for evaluation of immune reconstitution, T-cell differentiation status, NK-cell recovery, allo-reactivity of donor T-cells after transplantation, and regulatory T-cell reconstitution.
After completion of study therapy, patients are followed periodically for up to 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy or chemotherapy + total body irradiation | Experimental | Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Graft-versus-host Disease (GVHD) | Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria | |
| Severity of Acute Graft-versus-host Disease (GVHD) | Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria | |
| Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment. | Within 6 months after PBSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Chronic GVHD. | Within 2 years after PBSCT | |
| Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] ) | post transplant, up to 4 weeks | |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of a hematological malignancy, including any of the following:
Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)
Hodgkin lymphoma in CR or PR
Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:
In CR
Not in CR and meets the following criteria:
Myelodysplastic syndromes, treated or untreated
Chronic myeloid leukemia in chronic phase or accelerated phase
Multiple myeloma in CR or PR
Chronic lymphocytic leukemia in second or greater CR or PR
Myelofibrosis or other myeloproliferative disorders meeting the following criteria:
No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment, T-cell depletion, etc)
Scheduled to undergo peripheral blood stem cell transplantation from a suitable HLA-matched or -mismatched unrelated donor, as determined by treating physician
No documented uncontrolled CNS disease
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0-2
Karnofsky PS 60-100%
Creatinine clearance > 50 mL/min
Bilirubin < 3 times upper limit of normal (ULN)
ALT and AST < 3 times ULN
LVEF > 50%
FVC, FEV_1, or DLCO > 50% predicted
Able to cooperate with oral medication intake
HIV negative
No active hepatitis B or hepatitis C
No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zaid Al-Kadhimi, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Conditioning Regimen | Chemotherapy or chemotherapy + total body irradiation Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| busulfan | Drug | Given IV |
|
|
| carmustine | Drug | Given IV |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| cytarabine | Drug | Given IV |
|
|
| etoposide | Drug | Given IV |
|
|
| fludarabine phosphate | Drug | Given IV |
|
|
| melphalan | Drug | Given IV |
|
|
| total body irradiation (TBI) | Radiation | Given once or twice daily |
|
|
| anti-thymocyte globulin IV | Drug | Given IV |
|
|
| Overall Survival. |
| At 2 years after PBSCT |
| Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders) | Within 6 months after PBSCT |
| Karnofsky Performance Status Performance Status | 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead | At 90 days after PBSCT |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All regimens were analyzed together. Standard of Care (SOC) Chemotherapy or Standard of Care (SOC) Chemotherapy + total body irradiation SOC chemotherapy or SOC chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI. |
| 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 |
| ||||||||||||||||||
| 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 | Incidence of Acute Graft-versus-host Disease (GVHD) | Posted | Number | 90% Confidence Interval | percentage of participants | Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria |
|
|
| |||||||||||||||||||||||||||
| Primary | Severity of Acute Graft-versus-host Disease (GVHD) | The patients that contracted sever acute graph versus host disease (aGVHD) from those who developed aGVHD | Posted | Number | 90% Confidence Interval | % of participants with severe aGVHD | Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria |
|
| |||||||||||||||||||||||||||
| Primary | Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment. | All participants | Posted | Number | 95% Confidence Interval | % of participants with a reported SAE | Within 6 months after PBSCT |
|
|
| ||||||||||||||||||||||||||
| Secondary | Incidence of Chronic GVHD. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | Within 2 years after PBSCT |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] ) | All participants | Posted | Median | Full Range | Days | post transplant, up to 4 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival. | Posted | Number | 95% Confidence Interval | percentage of participants | At 2 years after PBSCT |
|
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders) | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | Within 6 months after PBSCT |
|
|
| ||||||||||||||||||||||||||
| Secondary | Karnofsky Performance Status Performance Status | 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead | All participants | Posted | Median | Full Range | units on a scale | At 90 days after PBSCT |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conditioning Regimen | Chemotherapy or chemotherapy + total body irradiation Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI. | 44 | 47 | 0 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alanine aminotransferase (ALT) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| alanine aminotransferase (ALT), SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| aspartate aminotransferase (AST) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| aspartate aminotransferase (AST) increased, SGOT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline Phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood/Bone Marrow | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Calcium serum - low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiopulmonary arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatology/Skin - palmar erythema | Skin and subcutaneous tissue 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 |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Glucose | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, GI | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, GI-Liver | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory/lung | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage/bleeding associated with surgery, intra-operative or postoperative | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobiliary/Pancreas - Other (VOD/SOS) | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular 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 |
| |
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection BK | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection CMV | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection EBV | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection HSV | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection VZV in CSF | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections aspergillus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Pulmonary | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| infection, with normal ANC | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection-Pulmonary/Upper Resp. | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Iron Overload | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left Ventricular diastolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left Ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Liver Dysfunction/Failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocytes | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Magnesium, Serum high | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Magnesium, Serum low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| mood alteration | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis/stomatis-large bowel | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis/stomatis-Small bowel | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other-Right side facial droop | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Pulmonary/Respiratroy-throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Gastrointestinal-Abdominal NOS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-mid/back, hip | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Cardiovascular-cardiac/heart | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Gastrointestinal-oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-gastrointestinal-stomach | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Musculoskeletal-Back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Musculoskeletal-Bone | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Neurology-head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-Neurology-headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| pain-renal/genitourinary | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| pain-chest wall | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Potassium, Serum high | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Potassium, serum low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| prolonged intubation | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal-other-Acute Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sodium, Serum-low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/embolism/thrombus | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/embolism (left lower extremity) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/embolism (pulmonary) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular arrhythmia-ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-disease progression | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-disease progression NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-GVHD | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death SOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-cGVHD | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-aGVHD/infection | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-Multi organ failure | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-Multi organ failure/SOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-Multi organ failure/Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Death-pancytopenia possible bleed | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-Disease progression (from 2nd BMT not associated with this protocol) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-aGVHD | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death-intersititial pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zaid Al-Kadhimi, M. D. | Barbara Ann Karmanos Institute | (404) 778-1900 | zalkadh@emory.edu |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D000013 | Congenital Abnormalities |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015470 | Leukemia, Myeloid, Acute |
| D055728 | Primary Myelofibrosis |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015467 | Leukemia, Neutrophilic, Chronic |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| 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 |
| 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 |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D002066 | Busulfan |
| D002330 | Carmustine |
| C574855 | carmustine, poliferprosan 20 drug combination |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| C512542 | thymoglobulin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Title | Denominators | Categories |
|---|
|
|
|
|
|
| Denominators |
|---|
| Categories |
|---|
|
|