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The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
This study will determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous (SC) Treatment Plan - Donor | Active Comparator |
|
|
| Intravenous (IV) Treatment Plan - Donor | Experimental |
|
|
| Recipients | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMD3100 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only) | -Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight] | Day 1-3 |
| Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only) | -Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria | By Day 100 after transplant |
| Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only) | -Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir | Day +21 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Recipients Who Experience Chronic GVHD (Recipient Only) | -Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria | Between Day +100 and +365 post-transplant |
| Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only) |
Not provided
Inclusion Criteria:
Donor criteria:
Donor is 18 to 70 years of age inclusive
If female and of child-bearing age, must be:
Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for transplant
Donor must be willing to provide written informed consent.
Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis
Adequate neurologic function as defined by:
Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test.
Must have an ECOG performance status of 0 or 1
Must demonstrate ability to be compliant with study regimen.
Must not have an active infection at the time of study entry
Not have active alcohol or substance abuse within 6 months of study entry
Not currently enrolled in another investigational agent study
Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation
Recipient criteria:
18 to 65 years of age inclusive
Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant
Provide signed informed consent
If female and of child-bearing age, must be:
Patient must have one of the following diagnoses:
AML in 1st or subsequent remission or in relapse
ALL in 1st or subsequent remission or in relapse
MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System
CML in accelerated or second chronic phase
NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse
CLL Rai Stage 2-4, failing at least 2 prior regimens
MM Stage 2-3
Adequate cardiac function with a left ventricular ejection fraction ≥ 40%
Adequate pulmonary function defined as:
Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis
Adequate neurologic function as defined by no evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain
No evidence of active infection at the time of the transplant preparative regimen or at the time of transplantation
Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test
ECOG performance status of 0 or 1
Must demonstrate ability to be compliant with medical regimen
Not have active alcohol or substance abuse within 6 months of study entry
Not be concurrently enrolled on another study involving an investigational agent
Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient
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| Name | Affiliation | Role |
|---|---|---|
| John F. DiPersio, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18426988 | Background | Devine SM, Vij R, Rettig M, Todt L, McGlauchlen K, Fisher N, Devine H, Link DC, Calandra G, Bridger G, Westervelt P, Dipersio JF. Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction. Blood. 2008 Aug 15;112(4):990-8. doi: 10.1182/blood-2007-12-130179. Epub 2008 Apr 21. | |
| 15020611 |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study was opened to participant enrollment on 05/14/2004 and closed to participant enrollment on 01/26/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous (SC) Treatment Plan - Donor |
|
| FG001 | Recipients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Stem Cell Transplant | Procedure |
|
-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause |
| 100 days after transplant |
| Quality of Life During Stem Cell Mobilization (Recipients Only) | 48-72 hours after last dose of AMD3100 |
| Proportion of Donors Who Experience Infusional Toxicity (Donor Only) | -Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion | Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm) |
| To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax | -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion | 0 to 24 hours after dose of IV AMD3100 |
| To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity | -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion | 0 to 24 hours after dose of IV AMD3100 |
| Devine SM, Flomenberg N, Vesole DH, Liesveld J, Weisdorf D, Badel K, Calandra G, DiPersio JF. Rapid mobilization of CD34+ cells following administration of the CXCR4 antagonist AMD3100 to patients with multiple myeloma and non-Hodgkin's lymphoma. J Clin Oncol. 2004 Mar 15;22(6):1095-102. doi: 10.1200/JCO.2004.07.131. |
| 15890685 | Background | Flomenberg N, Devine SM, Dipersio JF, Liesveld JL, McCarty JM, Rowley SD, Vesole DH, Badel K, Calandra G. The use of AMD3100 plus G-CSF for autologous hematopoietic progenitor cell mobilization is superior to G-CSF alone. Blood. 2005 Sep 1;106(5):1867-74. doi: 10.1182/blood-2005-02-0468. Epub 2005 May 12. |
| 28292947 | Derived | Schroeder MA, Rettig MP, Lopez S, Christ S, Fiala M, Eades W, Mir FA, Shao J, McFarland K, Trinkaus K, Shannon W, Deych E, Yu J, Vij R, Stockerl-Goldstein K, Cashen AF, Uy GL, Abboud CN, Westervelt P, DiPersio JF. Mobilization of allogeneic peripheral blood stem cell donors with intravenous plerixafor mobilizes a unique graft. Blood. 2017 May 11;129(19):2680-2692. doi: 10.1182/blood-2016-09-739722. Epub 2017 Mar 14. |
|
| FG002 | Intravenous (IV) Treatment Plan - Donor |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous (SC) Treatment Plan - Donor |
|
| BG001 | Recipients |
|
| BG002 | Intravenous (IV) Treatment Plan - Donor |
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, 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 | Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only) | -Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight] | Posted | Count of Participants | Participants | Day 1-3 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only) | -Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria | Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells. | Posted | Count of Participants | Participants | By Day 100 after transplant |
| ||||||||||||||||||||||||||||||||||
| Primary | Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only) | -Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir | Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells. | Posted | Count of Participants | Participants | Day +21 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Recipients Who Experience Chronic GVHD (Recipient Only) | -Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria | Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100. | Posted | Count of Participants | Participants | Between Day +100 and +365 post-transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only) | -Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause | Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells. | Posted | Count of Participants | Participants | 100 days after transplant |
| ||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life During Stem Cell Mobilization (Recipients Only) | -Quality of life questionnaires were not collected from the recipients. | Posted | 48-72 hours after last dose of AMD3100 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Donors Who Experience Infusional Toxicity (Donor Only) | -Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion | Posted | Count of Participants | Participants | Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm) |
| |||||||||||||||||||||||||||||||||||
| Secondary | To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax | -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion | Pharmacokinetics were not performed on 2 patients who were considered replacement patients. | Posted | Mean | Full Range | ng/ml | 0 to 24 hours after dose of IV AMD3100 |
| |||||||||||||||||||||||||||||||||
| Secondary | To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity | -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion | Pharmacokinetics were not performed on 2 patients who were considered replacement patients. | Posted | Mean | Full Range | ng*hr/mL | 0 to 24 hours after dose of IV AMD3100 |
|
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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 | Donors | AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3 | 2 | 46 | 46 | 46 | ||
| EG001 | Recipients | Stem Cell Transplantation Day 0 | 12 | 46 | 46 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ankle pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| C. Difficile infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Death due to disease progression | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema - extremities | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Emesis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erythemous rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Generalized weakness | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Increased bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Increased creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Iron deficiency | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mouth pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pancytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vasovagal reaction | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anasarca | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ankle pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arm pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bronchospasm wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cold sensation | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Distension/abdominal bloating | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Extrapyramidal involuntary movement | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Extremity walking (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Facial edema (head and neck) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Feet tremor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fistula, GI | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Foliculitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| G-tube site infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Generalized weakness | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hand tremor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoptisis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hip pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Interstitial pneumonia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Knee pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leg pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lower extremities edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mental status change | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mood alteration | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Non-specific ST abnormality | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Otitis, middle ear | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Paranasal reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Petequiae | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Shoulder blade pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Spine pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Spine pain | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Throat pain | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism (DVT) | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| U wave | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary color change | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Vasovagal episode | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Viremia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Vitreous hemorrhage | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Warm sensation | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Watery eye (tearing) | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John F. DiPersio, M.D., Ph.D. | Washington University School of Medicine | 314-454-8603 | jdipersi@wustl.edu |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009190 | Myelodysplastic Syndromes |
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008223 | Lymphoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C088327 | plerixafor |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Male |
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