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Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01168219
Recruitment Status : Active, not recruiting
First Posted : July 23, 2010
Results First Posted : April 3, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
de Novo Myelodysplastic Syndrome
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Secondary Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Interventions Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Azacitidine
Drug: Busulfan
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Other: Pharmacological Study
Drug: Tacrolimus
Enrollment 68
Recruitment Details From July 2010 and October 2013, a total of 68 participants were recruited to this study.
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy and Transplant)
Hide Arm/Group Description

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). >

> TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. >

> GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). >

> CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.

Period Title: Overall Study
Started 68
Completed 68
Not Completed 0
Arm/Group Title Treatment (Chemotherapy and Transplant)
Hide Arm/Group Description

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). >

> TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. >

> GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). >

> CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.

Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
62.9
(44.8 to 74.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
15
  22.1%
Male
53
  77.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Hispanic or Latino
3
   4.4%
Not Hispanic or Latino
61
  89.7%
Unknown or Not Reported
4
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
American Indian or Alaska Native
1
   1.5%
Asian
2
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.5%
White
60
  88.2%
More than one race
2
   2.9%
Unknown or Not Reported
2
   2.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
 100.0%
Disease type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Myelodysplastic Syndrome (MDS)
24
  35.3%
Acute Myeloid Leukemia (AML)
44
  64.7%
1.Primary Outcome
Title Progression-free Survival
Hide Description

Number of patients who were alive and progression-free at 2 years. >

> AML progression is defined as: >

  • Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow >
  • If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts >
  • Development of extramedullary leukemia >

MDS progression is defined as >

  • For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts >
  • For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts >
  • Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate
Time Frame At 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received transplant were evaluable for the primary endpoint; 3 patients did not and were excluded from this analysis.
Arm/Group Title Treatment (Chemotherapy and Transplant)
Hide Arm/Group Description:

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). >

> TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. >

> GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). >

> CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.

Overall Number of Participants Analyzed 65
Measure Type: Count of Participants
Unit of Measure: Participants
24
  36.9%
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Estimated using the Kaplan-Meier product limit estimator.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Treatment Related Mortality (TRM)
Hide Description TRM is defined as death within the first six months after transplant not secondary to relapse.
Time Frame Up to 6 months post-treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy and Transplant)
Hide Arm/Group Description CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
All-Cause Mortality
Treatment (Chemotherapy and Transplant)
Affected / at Risk (%)
Total   14/66 (21.21%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy and Transplant)
Affected / at Risk (%) # Events
Total   22/66 (33.33%)    
Blood and lymphatic system disorders   
Anemia  1  18/66 (27.27%)  19
Blood and lymphatic system disorders - Other, specify  1  1/66 (1.52%)  1
Disseminated intravascular coagulation  1  1/66 (1.52%)  1
Febrile neutropenia  1  3/66 (4.55%)  3
Cardiac disorders   
Atrial fibrillation  1  3/66 (4.55%)  3
Cardiac arrest  1  2/66 (3.03%)  2
Conduction disorder  1  1/66 (1.52%)  1
Heart failure  1  2/66 (3.03%)  2
Left ventricular systolic dysfunction  1  1/66 (1.52%)  1
Sinus bradycardia  1  4/66 (6.06%)  4
Sinus tachycardia  1  7/66 (10.61%)  7
Supraventricular tachycardia  1  1/66 (1.52%)  1
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify  1  1/66 (1.52%)  1
Ear pain  1  3/66 (4.55%)  3
Hearing impaired  1  1/66 (1.52%)  1
Endocrine disorders   
Cushingoid  1  1/66 (1.52%)  1
Growth accelerated  1  1/66 (1.52%)  1
Eye disorders   
Blurred vision  1  1/66 (1.52%)  1
Cataract  1  1/66 (1.52%)  1
Dry eye  1  1/66 (1.52%)  1
Eye disorders - Other, specify  1  4/66 (6.06%)  4
Scleral disorder  1  1/66 (1.52%)  1
Vitreous hemorrhage  1  1/66 (1.52%)  1
Gastrointestinal disorders   
Abdominal distension  1  2/66 (3.03%)  2
Abdominal pain  1  7/66 (10.61%)  7
Ascites  1  1/66 (1.52%)  1
Constipation  1  5/66 (7.58%)  5
Diarrhea  1  12/66 (18.18%)  13
Dry mouth  1  4/66 (6.06%)  4
Dyspepsia  1  2/66 (3.03%)  2
Enterocolitis  1  1/66 (1.52%)  1
Esophagitis  1  1/66 (1.52%)  1
Fecal incontinence  1  3/66 (4.55%)  3
Gastrointestinal disorders - Other, specify  1  6/66 (9.09%)  7
Hemorrhoids  1  3/66 (4.55%)  3
Intra-abdominal hemorrhage  1  1/66 (1.52%)  1
Lower gastrointestinal hemorrhage  1  1/66 (1.52%)  1
Mucositis oral  1  4/66 (6.06%)  4
Nausea  1  11/66 (16.67%)  13
Oral hemorrhage  1  1/66 (1.52%)  1
Oral pain  1  1/66 (1.52%)  1
Rectal hemorrhage  1  1/66 (1.52%)  1
Rectal pain  1  1/66 (1.52%)  1
Vomiting  1  8/66 (12.12%)  9
General disorders   
Chills  1  4/66 (6.06%)  4
Death NOS  1  1/66 (1.52%)  1
Edema face  1  2/66 (3.03%)  2
Edema limbs  1  10/66 (15.15%)  12
Edema trunk  1  3/66 (4.55%)  3
Fatigue  1  12/66 (18.18%)  13
Fever  1  2/66 (3.03%)  2
General disorders and administration site conditions - Other, specify  1  2/66 (3.03%)  2
Hypothermia  1  1/66 (1.52%)  1
Localized edema  1  1/66 (1.52%)  1
Malaise  1  2/66 (3.03%)  2
Non-cardiac chest pain  1  1/66 (1.52%)  2
Pain  1  3/66 (4.55%)  3
Hepatobiliary disorders   
Cholecystitis  1  1/66 (1.52%)  1
Hepatic failure  1  2/66 (3.03%)  2
Hepatic hemorrhage  1  1/66 (1.52%)  1
Portal vein thrombosis  1  1/66 (1.52%)  1
Infections and infestations   
Catheter related infection  1  1/66 (1.52%)  1
Enterocolitis infectious  1  1/66 (1.52%)  1
Infections and infestations - Other, specify  1  6/66 (9.09%)  6
Lung infection  1  6/66 (9.09%)  7
Mucosal infection  1  2/66 (3.03%)  2
Sepsis  1  4/66 (6.06%)  4
Sinusitis  1  1/66 (1.52%)  1
Upper respiratory infection  1  1/66 (1.52%)  1
Urinary tract infection  1  1/66 (1.52%)  1
Injury, poisoning and procedural complications   
Bruising  1  4/66 (6.06%)  4
Fall  1  2/66 (3.03%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  5/66 (7.58%)  5
Alanine aminotransferase increased  1  11/66 (16.67%)  11
Alkaline phosphatase increased  1  10/66 (15.15%)  10
Aspartate aminotransferase increased  1  11/66 (16.67%)  11
Blood bilirubin increased  1  7/66 (10.61%)  7
Cholesterol high  1  1/66 (1.52%)  1
Creatinine increased  1  10/66 (15.15%)  11
Ejection fraction decreased  1  1/66 (1.52%)  1
Electrocardiogram QT corrected interval prolonged  1  1/66 (1.52%)  1
Fibrinogen decreased  1  2/66 (3.03%)  2
INR increased  1  3/66 (4.55%)  3
Investigations - Other, specify  1  3/66 (4.55%)  9
Lymphocyte count decreased  1  5/66 (7.58%)  5
Neutrophil count decreased  1  10/66 (15.15%)  11
Platelet count decreased  1  16/66 (24.24%)  17
Weight gain  1  1/66 (1.52%)  1
Weight loss  1  5/66 (7.58%)  7
White blood cell decreased  1  8/66 (12.12%)  8
Metabolism and nutrition disorders   
Acidosis  1  3/66 (4.55%)  4
Alkalosis  1  2/66 (3.03%)  2
Anorexia  1  9/66 (13.64%)  9
Dehydration  1  1/66 (1.52%)  1
Hypercalcemia  1  1/66 (1.52%)  1
Hyperglycemia  1  14/66 (21.21%)  15
Hyperkalemia  1  5/66 (7.58%)  5
Hypermagnesemia  1  1/66 (1.52%)  1
Hypernatremia  1  3/66 (4.55%)  3
Hypertriglyceridemia  1  1/66 (1.52%)  1
Hyperuricemia  1  1/66 (1.52%)  1
Hypoalbuminemia  1  10/66 (15.15%)  11
Hypocalcemia  1  7/66 (10.61%)  8
Hypoglycemia  1  3/66 (4.55%)  3
Hypokalemia  1  4/66 (6.06%)  4
Hypomagnesemia  1  11/66 (16.67%)  12
Hyponatremia  1  9/66 (13.64%)  10
Hypophosphatemia  1  5/66 (7.58%)  5
Metabolism and nutrition disorders - Other, specify  1  6/66 (9.09%)  8
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/66 (6.06%)  4
Back pain  1  3/66 (4.55%)  3
Generalized muscle weakness  1  5/66 (7.58%)  6
Musculoskeletal and connective tissue disorder - Other, specify  1  1/66 (1.52%)  1
Myalgia  1  2/66 (3.03%)  2
Pain in extremity  1  3/66 (4.55%)  4
Soft tissue necrosis lower limb  1  1/66 (1.52%)  1
Soft tissue necrosis upper limb  1  1/66 (1.52%)  1
Nervous system disorders   
Akathisia  1  1/66 (1.52%)  1
Depressed level of consciousness  1  2/66 (3.03%)  2
Dizziness  1  2/66 (3.03%)  2
Dysgeusia  1  6/66 (9.09%)  6
Encephalopathy  1  1/66 (1.52%)  1
Extrapyramidal disorder  1  1/66 (1.52%)  1
Headache  1  2/66 (3.03%)  2
Hypersomnia  1  1/66 (1.52%)  1
Lethargy  1  1/66 (1.52%)  1
Neuralgia  1  1/66 (1.52%)  1
Paresthesia  1  1/66 (1.52%)  1
Peripheral sensory neuropathy  1  3/66 (4.55%)  3
Presyncope  1  1/66 (1.52%)  1
Sinus pain  1  1/66 (1.52%)  1
Somnolence  1  1/66 (1.52%)  1
Syncope  1  1/66 (1.52%)  1
Tremor  1  1/66 (1.52%)  1
Psychiatric disorders   
Anxiety  1  4/66 (6.06%)  4
Confusion  1  2/66 (3.03%)  2
Delirium  1  1/66 (1.52%)  1
Depression  1  3/66 (4.55%)  3
Hallucinations  1  1/66 (1.52%)  1
Insomnia  1  4/66 (6.06%)  4
Psychiatric disorders - Other, specify  1  1/66 (1.52%)  1
Renal and urinary disorders   
Acute kidney injury  1  4/66 (6.06%)  4
Chronic kidney disease  1  2/66 (3.03%)  2
Hematuria  1  1/66 (1.52%)  1
Renal and urinary disorders - Other, specify  1  2/66 (3.03%)  2
Urinary frequency  1  1/66 (1.52%)  1
Urinary incontinence  1  1/66 (1.52%)  1
Urinary retention  1  1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  3/66 (4.55%)  3
Cough  1  6/66 (9.09%)  6
Dyspnea  1  8/66 (12.12%)  8
Epistaxis  1  3/66 (4.55%)  3
Hypoxia  1  7/66 (10.61%)  8
Nasal congestion  1  3/66 (4.55%)  3
Pleural effusion  1  2/66 (3.03%)  2
Pleural hemorrhage  1  1/66 (1.52%)  1
Pneumonitis  1  3/66 (4.55%)  3
Pneumothorax  1  3/66 (4.55%)  3
Postnasal drip  1  1/66 (1.52%)  1
Productive cough  1  2/66 (3.03%)  2
Pulmonary fibrosis  1  1/66 (1.52%)  1
Pulmonary hypertension  1  1/66 (1.52%)  1
Respiratory failure  1  5/66 (7.58%)  5
Respiratory, thoracic and mediastinal disorders - Other, specify  1  3/66 (4.55%)  5
Skin and subcutaneous tissue disorders   
Dry skin  1  4/66 (6.06%)  4
Nail loss  1  1/66 (1.52%)  1
Pain of skin  1  3/66 (4.55%)  3
Rash maculo-papular  1  5/66 (7.58%)  6
Skin and subcutaneous tissue disorders - Other, specify  1  3/66 (4.55%)  9
Skin hypopigmentation  1  1/66 (1.52%)  1
Skin ulceration  1  1/66 (1.52%)  1
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  1/66 (1.52%)  1
Vascular disorders   
Flushing  1  1/66 (1.52%)  1
Hot flashes  1  1/66 (1.52%)  1
Hypertension  1  9/66 (13.64%)  9
Hypotension  1  10/66 (15.15%)  12
Thromboembolic event  1  3/66 (4.55%)  3
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy and Transplant)
Affected / at Risk (%) # Events
Total   61/66 (92.42%)    
Blood and lymphatic system disorders   
Anemia  1  58/66 (87.88%)  219
Blood and lymphatic system disorders - Other, specify  1  2/66 (3.03%)  3
Febrile neutropenia  1  21/66 (31.82%)  24
Hemolysis  1  1/66 (1.52%)  5
Leukocytosis  1  4/66 (6.06%)  5
Thrombotic thrombocytopenic purpura  1  1/66 (1.52%)  2
Cardiac disorders   
Atrial fibrillation  1  8/66 (12.12%)  21
Atrial flutter  1  1/66 (1.52%)  1
Cardiac disorders - Other, specify  1  1/66 (1.52%)  1
Chest pain - cardiac  1  2/66 (3.03%)  2
Heart failure  1  1/66 (1.52%)  1
Left ventricular systolic dysfunction  1  1/66 (1.52%)  1
Myocarditis  1  1/66 (1.52%)  1
Palpitations  1  1/66 (1.52%)  1
Paroxysmal atrial tachycardia  1  1/66 (1.52%)  1
Pericardial effusion  1  1/66 (1.52%)  1
Restrictive cardiomyopathy  1  1/66 (1.52%)  1
Sinus bradycardia  1  15/66 (22.73%)  20
Sinus tachycardia  1  17/66 (25.76%)  28
Supraventricular tachycardia  1  1/66 (1.52%)  1
Ventricular arrhythmia  1  1/66 (1.52%)  1
Ventricular tachycardia  1  1/66 (1.52%)  1
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify  1  1/66 (1.52%)  2
Ear pain  1  3/66 (4.55%)  3
Hearing impaired  1  3/66 (4.55%)  13
Vertigo  1  1/66 (1.52%)  1
Endocrine disorders   
Adrenal insufficiency  1  1/66 (1.52%)  2
Endocrine disorders - Other, specify  1  3/66 (4.55%)  3
Hypothyroidism  1  1/66 (1.52%)  7
Eye disorders   
Blurred vision  1  18/66 (27.27%)  45
Cataract  1  2/66 (3.03%)  4
Conjunctivitis  1  2/66 (3.03%)  2
Dry eye  1  10/66 (15.15%)  21
Eye disorders - Other, specify  1  8/66 (12.12%)  8
Eye pain  1  4/66 (6.06%)  5
Glaucoma  1  2/66 (3.03%)  9
Photophobia  1  2/66 (3.03%)  2
Scleral disorder  1  1/66 (1.52%)  1
Uveitis  1  1/66 (1.52%)  4
Vitreous hemorrhage  1  1/66 (1.52%)  1
Watering eyes  1  5/66 (7.58%)  6
Gastrointestinal disorders   
Abdominal distension  1  5/66 (7.58%)  8
Abdominal pain  1  23/66 (34.85%)  36
Anal pain  1  1/66 (1.52%)  1
Bloating  1  3/66 (4.55%)  6
Colitis  1  1/66 (1.52%)  1
Constipation  1  32/66 (48.48%)  54
Diarrhea  1  52/66 (78.79%)  87
Dry mouth  1  19/66 (28.79%)  42
Dyspepsia  1  11/66 (16.67%)  28
Dysphagia  1  10/66 (15.15%)  10
Esophageal pain  1  1/66 (1.52%)  1
Fecal incontinence  1  3/66 (4.55%)  3
Flatulence  1  3/66 (4.55%)  3
Gastritis  1  2/66 (3.03%)  2
Gastroesophageal reflux disease  1  9/66 (13.64%)  15
Gastrointestinal disorders - Other, specify  1  12/66 (18.18%)  22
Gastrointestinal pain  1  1/66 (1.52%)  1
Hemorrhoidal hemorrhage  1  4/66 (6.06%)  4
Hemorrhoids  1  6/66 (9.09%)  7
Ileus  1  1/66 (1.52%)  1
Mucositis oral  1  47/66 (71.21%)  56
Nausea  1  48/66 (72.73%)  111
Oral hemorrhage  1  7/66 (10.61%)  7
Oral pain  1  11/66 (16.67%)  14
Periodontal disease  1  1/66 (1.52%)  1
Proctitis  1  1/66 (1.52%)  1
Rectal hemorrhage  1  1/66 (1.52%)  1
Rectal pain  1  3/66 (4.55%)  4
Rectal ulcer  1  1/66 (1.52%)  1
Stomach pain  1  1/66 (1.52%)  1
Toothache  1  1/66 (1.52%)  1
Vomiting  1  40/66 (60.61%)  57
General disorders   
Chills  1  21/66 (31.82%)  30
Edema face  1  7/66 (10.61%)  8
Edema limbs  1  24/66 (36.36%)  56
Edema trunk  1  3/66 (4.55%)  3
Facial pain  1  1/66 (1.52%)  1
Fatigue  1  50/66 (75.76%)  155
Fever  1  26/66 (39.39%)  28
Flu like symptoms  1  1/66 (1.52%)  1
General disorders and administration site conditions - Other, specify  1  5/66 (7.58%)  5
Infusion related reaction  1  5/66 (7.58%)  7
Injection site reaction  1  8/66 (12.12%)  13
Localized edema  1  2/66 (3.03%)  2
Malaise  1  1/66 (1.52%)  1
Neck edema  1  1/66 (1.52%)  1
Non-cardiac chest pain  1  12/66 (18.18%)  16
Pain  1  11/66 (16.67%)  20
Hepatobiliary disorders   
Hepatobiliary disorders - Other, specify  1  3/66 (4.55%)  10
Immune system disorders   
Immune system disorders - Other, specify  1  1/66 (1.52%)  4
Infections and infestations   
Bladder infection  1  3/66 (4.55%)  4
Bronchial infection  1  1/66 (1.52%)  1
Catheter related infection  1  1/66 (1.52%)  1
Device related infection  1  1/66 (1.52%)  1
Enterocolitis infectious  1  2/66 (3.03%)  2
Infections and infestations - Other, specify  1  29/66 (43.94%)  46
Lip infection  1  1/66 (1.52%)  1
Lung infection  1  6/66 (9.09%)  8
Meningitis  1  1/66 (1.52%)  1
Mucosal infection  1  6/66 (9.09%)  16
Nail infection  1  1/66 (1.52%)  1
Papulopustular rash  1  3/66 (4.55%)  3
Rash pustular  1  1/66 (1.52%)  1
Sepsis  1  5/66 (7.58%)  7
Sinusitis  1  1/66 (1.52%)  4
Skin infection  1  3/66 (4.55%)  3
Soft tissue infection  1  2/66 (3.03%)  3
Tooth infection  1  1/66 (1.52%)  1
Upper respiratory infection  1  7/66 (10.61%)  8
Urinary tract infection  1  4/66 (6.06%)  5
Injury, poisoning and procedural complications   
Bruising  1  12/66 (18.18%)  21
Fall  1  2/66 (3.03%)  2
Injury, poisoning and procedural complications - Other, specify  1  1/66 (1.52%)  1
Spinal fracture  1  1/66 (1.52%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  7/66 (10.61%)  15
Alanine aminotransferase increased  1  40/66 (60.61%)  99
Alkaline phosphatase increased  1  23/66 (34.85%)  48
Aspartate aminotransferase increased  1  36/66 (54.55%)  90
Blood bilirubin increased  1  21/66 (31.82%)  26
Cholesterol high  1  1/66 (1.52%)  1
Creatinine increased  1  35/66 (53.03%)  74
Fibrinogen decreased  1  1/66 (1.52%)  1
GGT increased  1  3/66 (4.55%)  10
INR increased  1  6/66 (9.09%)  11
Investigations - Other, specify  1  4/66 (6.06%)  32
Lymphocyte count decreased  1  28/66 (42.42%)  92
Neutrophil count decreased  1  56/66 (84.85%)  115
Platelet count decreased  1  56/66 (84.85%)  194
Weight gain  1  3/66 (4.55%)  5
Weight loss  1  20/66 (30.30%)  44
White blood cell decreased  1  35/66 (53.03%)  77
Metabolism and nutrition disorders   
Anorexia  1  39/66 (59.09%)  91
Dehydration  1  8/66 (12.12%)  9
Glucose intolerance  1  1/66 (1.52%)  1
Hypercalcemia  1  5/66 (7.58%)  10
Hyperglycemia  1  54/66 (81.82%)  156
Hyperkalemia  1  24/66 (36.36%)  36
Hypermagnesemia  1  2/66 (3.03%)  2
Hypernatremia  1  5/66 (7.58%)  5
Hypertriglyceridemia  1  1/66 (1.52%)  1
Hyperuricemia  1  3/66 (4.55%)  9
Hypoalbuminemia  1  38/66 (57.58%)  69
Hypocalcemia  1  40/66 (60.61%)  64
Hypoglycemia  1  5/66 (7.58%)  6
Hypokalemia  1  33/66 (50.00%)  45
Hypomagnesemia  1  41/66 (62.12%)  104
Hyponatremia  1  36/66 (54.55%)  72
Hypophosphatemia  1  18/66 (27.27%)  22
Metabolism and nutrition disorders - Other, specify  1  12/66 (18.18%)  37
Obesity  1  1/66 (1.52%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  9/66 (13.64%)  21
Arthritis  1  1/66 (1.52%)  7
Back pain  1  14/66 (21.21%)  29
Bone pain  1  8/66 (12.12%)  10
Buttock pain  1  2/66 (3.03%)  4
Flank pain  1  4/66 (6.06%)  7
Generalized muscle weakness  1  21/66 (31.82%)  41
Muscle weakness left-sided  1  1/66 (1.52%)  1
Muscle weakness lower limb  1  2/66 (3.03%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1  11/66 (16.67%)  22
Myalgia  1  7/66 (10.61%)  12
Myositis  1  1/66 (1.52%)  1
Neck pain  1  4/66 (6.06%)  5
Osteoporosis  1  1/66 (1.52%)  1
Pain in extremity  1  11/66 (16.67%)  31
Nervous system disorders   
Akathisia  1  2/66 (3.03%)  2
Amnesia  1  1/66 (1.52%)  3
Dizziness  1  16/66 (24.24%)  24
Dysgeusia  1  25/66 (37.88%)  51
Encephalopathy  1  1/66 (1.52%)  1
Headache  1  29/66 (43.94%)  42
Hydrocephalus  1  1/66 (1.52%)  1
Hypersomnia  1  1/66 (1.52%)  1
Intracranial hemorrhage  1  1/66 (1.52%)  1
Lethargy  1  4/66 (6.06%)  4
Memory impairment  1  2/66 (3.03%)  3
Nervous system disorders - Other, specify  1  1/66 (1.52%)  1
Neuralgia  1  1/66 (1.52%)  2
Paresthesia  1  2/66 (3.03%)  3
Peripheral motor neuropathy  1  5/66 (7.58%)  6
Peripheral sensory neuropathy  1  13/66 (19.70%)  36
Presyncope  1  1/66 (1.52%)  1
Sinus pain  1  3/66 (4.55%)  4
Somnolence  1  3/66 (4.55%)  3
Stroke  1  1/66 (1.52%)  1
Syncope  1  2/66 (3.03%)  2
Transient ischemic attacks  1  1/66 (1.52%)  2
Tremor  1  13/66 (19.70%)  20
Vasovagal reaction  1  1/66 (1.52%)  1
Psychiatric disorders   
Agitation  1  1/66 (1.52%)  3
Anxiety  1  18/66 (27.27%)  39
Confusion  1  13/66 (19.70%)  14
Delirium  1  1/66 (1.52%)  1
Depression  1  11/66 (16.67%)  35
Hallucinations  1  2/66 (3.03%)  2
Insomnia  1  24/66 (36.36%)  54
Psychiatric disorders - Other, specify  1  1/66 (1.52%)  1
Renal and urinary disorders   
Acute kidney injury  1  12/66 (18.18%)  23
Bladder spasm  1  2/66 (3.03%)  2
Chronic kidney disease  1  2/66 (3.03%)  3
Cystitis noninfective  1  2/66 (3.03%)  2
Hematuria  1  6/66 (9.09%)  6
Proteinuria  1  3/66 (4.55%)  4
Renal and urinary disorders - Other, specify  1  3/66 (4.55%)  4
Renal calculi  1  1/66 (1.52%)  2
Urinary frequency  1  10/66 (15.15%)  18
Urinary incontinence  1  3/66 (4.55%)  3
Urinary retention  1  5/66 (7.58%)  6
Urinary tract obstruction  1  1/66 (1.52%)  2
Urinary tract pain  1  7/66 (10.61%)  8
Urinary urgency  1  4/66 (6.06%)  4
Reproductive system and breast disorders   
Genital edema  1  3/66 (4.55%)  3
Irregular menstruation  1  1/66 (1.52%)  1
Penile pain  1  3/66 (4.55%)  3
Prostatic obstruction  1  1/66 (1.52%)  1
Reproductive system and breast disorders - Other, specify  1  1/66 (1.52%)  2
Scrotal pain  1  1/66 (1.52%)  1
Vaginal discharge  1  1/66 (1.52%)  1
Vaginal dryness  1  2/66 (3.03%)  2
Vaginal hemorrhage  1  1/66 (1.52%)  1
Vaginal inflammation  1  3/66 (4.55%)  3
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  6/66 (9.09%)  11
Atelectasis  1  1/66 (1.52%)  1
Bronchopulmonary hemorrhage  1  1/66 (1.52%)  1
Cough  1  21/66 (31.82%)  30
Dyspnea  1  29/66 (43.94%)  52
Epistaxis  1  12/66 (18.18%)  13
Hiccups  1  5/66 (7.58%)  5
Hypoxia  1  9/66 (13.64%)  9
Laryngeal hemorrhage  1  2/66 (3.03%)  2
Laryngeal mucositis  1  1/66 (1.52%)  1
Nasal congestion  1  15/66 (22.73%)  21
Pharyngeal mucositis  1  3/66 (4.55%)  4
Pleural effusion  1  4/66 (6.06%)  4
Pneumonitis  1  2/66 (3.03%)  2
Postnasal drip  1  4/66 (6.06%)  4
Productive cough  1  3/66 (4.55%)  3
Pulmonary edema  1  4/66 (6.06%)  4
Respiratory failure  1  1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  7/66 (10.61%)  9
Sneezing  1  1/66 (1.52%)  1
Sore throat  1  16/66 (24.24%)  24
Wheezing  1  3/66 (4.55%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  5/66 (7.58%)  16
Bullous dermatitis  1  3/66 (4.55%)  4
Dry skin  1  21/66 (31.82%)  43
Erythema multiforme  1  5/66 (7.58%)  11
Erythroderma  1  1/66 (1.52%)  2
Hyperhidrosis  1  3/66 (4.55%)  3
Nail loss  1  3/66 (4.55%)  9
Pain of skin  1  6/66 (9.09%)  8
Palmar-plantar erythrodysesthesia syndrome  1  1/66 (1.52%)  1
Pruritus  1  31/66 (46.97%)  50
Purpura  1  3/66 (4.55%)  4
Rash acneiform  1  6/66 (9.09%)  7
Rash maculo-papular  1  34/66 (51.52%)  58
Skin and subcutaneous tissue disorders - Other, specify  1  20/66 (30.30%)  55
Skin hyperpigmentation  1  8/66 (12.12%)  25
Skin hypopigmentation  1  3/66 (4.55%)  10
Skin ulceration  1  8/66 (12.12%)  12
Urticaria  1  3/66 (4.55%)  3
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  1/66 (1.52%)  1
Vascular disorders   
Flushing  1  2/66 (3.03%)  2
Hot flashes  1  2/66 (3.03%)  2
Hypertension  1  40/66 (60.61%)  106
Hypotension  1  21/66 (31.82%)  39
Phlebitis  1  1/66 (1.52%)  1
Superficial thrombophlebitis  1  1/66 (1.52%)  1
Thromboembolic event  1  7/66 (10.61%)  21
Vascular disorders - Other, specify  1  1/66 (1.52%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ravi Vij, MD
Organization: Washington University School of Medicine
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01168219     History of Changes
Other Study ID Numbers: NCI-2011-02053
NCI-2011-02053 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-100801
CDR0000681025
CALGB 100801 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-100801 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: March 5, 2018
Results First Posted: April 3, 2018
Last Update Posted: July 10, 2018