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| ID | Type | Description | Link |
|---|---|---|---|
| BMTGG-NSH-864 |
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RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of PBSCT, patients are followed periodically for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloablative Haploidentical Transplant | Experimental | All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| busulfan | Drug | 110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Graft Rejection for Patients at Day 100 | Number of patients who experienced graft rejection by Day 100 | Day 100 |
| Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4) | Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at Day 100 | Overall survival is assessed, without regard to disease status, post-transplant, at Day 100. | Day 100 |
| Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT) |
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DISEASE CHARACTERISTICS:
Diagnosis of one of the following high-risk hematologic malignancies:
Chronic myelogenous leukemia meeting one of the following criteria:
Acute myelogenous leukemia meeting the following criteria:
Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
Must meet one of the following criteria:
Myelodysplastic syndrome meeting at least one of the following criteria:
Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria:
Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
Must meet one of the following criteria:
Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria:
Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria:
No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant
Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Scott R. Solomon, MD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| H. Kent Holland, MD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Lawrence E. Morris, MD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | United States |
NA - this study did not use group assignments. All patients received the same preparative regimen consisting of Fludarabine 25 mg/m2 x 5 days, busulfan 110 mg/m2 x4 days, cyclophosphamide 14.5 mg x 2 days PRE transplant and cyclophosphamide 50 mg x2 days POST transplant
Patients were consented between 12/17/08 through 01/13/11. The transplants occured between 1/13/09 and 3/2/11
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| ID | Title | Description |
|---|---|---|
| FG000 | Haploidentical Transplant | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cyclophosphamide | Drug | 14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2). |
|
| fludarabine phosphate | Drug | 30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3) |
|
| mycophenolate mofetil | Drug | 15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD. |
|
|
| tacrolimus | Drug | 0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD. |
|
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Patients to received unmanipulated PBSCs on Day 0 |
|
|
| peripheral blood stem cell transplantation | Procedure | patients to receive unmanipulated PBSCs on day 0 |
|
|
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
| 1 year |
| Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | Day 30 |
| Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) | Day 100 |
| Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | Day 60 |
| Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | Day 90 |
| Overall Survival at 12 Months | Overall survival, defined as a patient being alive after transplant, is without regard to disease status. | 12 months |
| Disease Free Survival at 12 Months | Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point. | 12 months |
| Disease Free Survival at Day 100 | Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point. | Day 100 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Haploidentical Transplant | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| 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 |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | 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 Graft Rejection for Patients at Day 100 | Number of patients who experienced graft rejection by Day 100 | 20 patients were treated and able to be analyzed for graft rejection | Posted | Number | participants | Day 100 |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4) | Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence | 17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease | Posted | Number | participants | Day 100 |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival at Day 100 | Overall survival is assessed, without regard to disease status, post-transplant, at Day 100. | 20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival | Posted | Number | participants | Day 100 |
|
| |||||||||||||||||||||||||||
| Secondary | Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT) | Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease. | 6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality. | Posted | Number | participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 18 patients had Day 30 chimerism drawn | Posted | Number | participants | Day 30 |
|
| |||||||||||||||||||||||||||
| Secondary | Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) | 2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality | Posted | Number | participants | Day 100 |
|
| ||||||||||||||||||||||||||||
| Secondary | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 18 patients had chimerism drawn at Day 60 | Posted | Number | participants | Day 60 |
|
| |||||||||||||||||||||||||||
| Secondary | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 13 patients had chimerism drawn at Day 90 | Posted | Number | participants | Day 90 |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival at 12 Months | Overall survival, defined as a patient being alive after transplant, is without regard to disease status. | 20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year | Posted | Number | participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival at 12 Months | Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point. | 14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year | Posted | Number | participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival at Day 100 | Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point. | 17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100 | Posted | Number | participants | Day 100 |
|
|
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Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
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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 | Haploidentical Transplant | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant | 12 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute graft versus host disease | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Acute graft versus host disease as it relates to SAE reporting rather than the total number of patients who had GVHD |
|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| BK virus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE 3.0 | Systematic Assessment | This event is death as it relates to being a serious adverse event (rather than all deaths for the study) |
|
| Hemorrhagic Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia induced hemiparesis | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratory Insufficiency | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pericardial effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constitutional - feeling cold | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| abdominal cramping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| abdominal tenderness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| abnormal taste | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| ALK PHOS | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Altered taste | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alveolar hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ANC | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia/decreased appetite | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| BK virus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder pressure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| bladder spasms | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| bloating | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| c-diff | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| cardiomyopathy | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| chills | General disorders | CTCAE (3.0) | Systematic Assessment |
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| CMV | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Coag Neg Staph | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cvc bleeding | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cvc erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cvc tenderness/pain | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| decreased EF | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| diaphoresis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| difficulty swallowing | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dizziness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| drowsiness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dry eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dry lips | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| epistaxis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| facial edema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| flat affect | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| fluid overload | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| general deconditioning | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GERD/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI distress | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| gram + bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| hallucinations | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hearing loss | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hemorrhagic cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hemorrhoids | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hiccoughs | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hives | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyperbilirubinemia | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypercalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperkalemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypermagnesemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypernatremia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyperphosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperpigmented skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypoglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypophosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| increased oral secretions | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| increased PT | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lethargy | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lip lesion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| LE edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| MRSE | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| neck stiffness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| neutropenic fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| night sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| parainfluenza | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| penile pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| periorbital edema | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| peripheral neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| reactive airway disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rectal discomfort | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| renal insufficiency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| restlessness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| RSV | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| seasonal allergies | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| shoulder discomfort | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| sinus congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| sinus drainage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| skin discoloration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| skin tear | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| sore throat | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| staph epi | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| stool incontinence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| suprapubic pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| throat pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| tremors | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| unsteady gait | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary burning | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| vaginal spotting/bleeding | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| visual changes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| vomitting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| VRE | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased WBC | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Solomon | Blood and Marrow Transplant Group of Georgia | 404-255-1930 | ssolomon@bmtga.com |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D000013 | Congenital Abnormalities |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015470 | Leukemia, Myeloid, Acute |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015463 | Leukemia, Prolymphocytic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015448 | Leukemia, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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
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