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Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00703820
Recruitment Status : Active, not recruiting
First Posted : June 24, 2008
Results First Posted : April 2, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: Cytarabine
Drug: Daunorubicin
Drug: Etoposide
Drug: Clofarabine
Device: CliniMACS
Enrollment 324
Recruitment Details 324 participants enrolled between August 2008 and March 2017.
Pre-assignment Details Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.
Arm/Group Title Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine
Hide Arm/Group Description Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted. Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Period Title: Overall Study
Started 133 129
Completed 98 95
Not Completed 35 34
Reason Not Completed
Adverse Event             12             17
Death             5             0
Lack of Efficacy             11             11
Received non-protocol therapy             1             0
Physician Decision             4             5
Withdrawal by Subject             2             1
Arm/Group Title Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine Total
Hide Arm/Group Description Participants receive Cytarabine + Daunorubicin + Etoposide as a first course followed by risk-adapted therapy. Participants receive Clofarabine + Cytarabine as a first course followed by risk-adapted therapy. Total of all reporting groups
Overall Number of Baseline Participants 133 129 262
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 129 participants 262 participants
9.57  (6.00) 9.05  (6.40) 9.31  (6.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 129 participants 262 participants
Female 60 59 119
Male 73 70 143
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 129 participants 262 participants
Hispanic or Latino
28
  21.1%
17
  13.2%
45
  17.2%
Not Hispanic or Latino
99
  74.4%
110
  85.3%
209
  79.8%
Unknown or Not Reported
6
   4.5%
2
   1.6%
8
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 129 participants 262 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   4.5%
12
   9.3%
18
   6.9%
Native Hawaiian or Other Pacific Islander
1
   0.8%
1
   0.8%
2
   0.8%
Black or African American
20
  15.0%
21
  16.3%
41
  15.6%
White
100
  75.2%
81
  62.8%
181
  69.1%
More than one race
4
   3.0%
5
   3.9%
9
   3.4%
Unknown or Not Reported
2
   1.5%
9
   7.0%
11
   4.2%
1.Primary Outcome
Title Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry
Hide Description MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
Time Frame Day 22 MRD measurement after one course of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.
Arm/Group Title Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine
Hide Arm/Group Description:
Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Overall Number of Participants Analyzed 121 121
Measure Type: Count of Participants
Unit of Measure: Participants
MRD Positive 42 57
MRD Negative 79 64
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cytarabine+Daunorubicin+Etoposide, Clofarabine+Cytarabine
Comments The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.
Method Cochran-Mantel-Haenszel
Comments The p-value was computed using an exact, risk-group stratified, two-sided test.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
1.03 to 3.41
Estimation Comments The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.
2.Secondary Outcome
Title Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.
Hide Description [Not Specified]
Time Frame 3 years after completion of therapy
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.
Hide Description [Not Specified]
Time Frame 3 years after completion of therapy
Outcome Measure Data Not Reported
Time Frame Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine Stem Cell Donors
Hide Arm/Group Description Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted. Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted. This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
All-Cause Mortality
Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine Stem Cell Donors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/133 (30.83%)      32/129 (24.81%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine Stem Cell Donors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   127/133 (95.49%)      122/129 (94.57%)      0/29 (0.00%)    
Blood and lymphatic system disorders       
Febrile neutropenia (fever of unknown origin: not clinically or microbiologically documented)  1 [1]  90/133 (67.67%)  189 95/129 (73.64%)  194 0/29 (0.00%)  0
DIC (disseminated intravascular coagulation)  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Cardiac disorders       
Left ventricular systolic dysfunction  1  3/133 (2.26%)  3 0/129 (0.00%)  0 0/29 (0.00%)  0
Valvular heart disease  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Cardiac arrhythmia - other  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Cardiac general - other  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Prolonged QTc interval  1  3/133 (2.26%)  4 2/129 (1.55%)  2 0/29 (0.00%)  0
Supraventricular and nodal arrhythmia, sinus bradycardia  1  1/133 (0.75%)  1 2/129 (1.55%)  2 0/29 (0.00%)  0
Right ventricular dysfunction (cor pulmonale)  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Pericardial effusion (non-malignant)  1  2/133 (1.50%)  2 1/129 (0.78%)  1 0/29 (0.00%)  0
Left ventricular diastolic dysfunction  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Supraventricular and nodal arrhythmia, sinus tachycardia  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Ear and labyrinth disorders       
Otitis, middle ear (non-infectious)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Tinnitus  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Eye disorders       
Neutrophils/granulocytes (ANC/AGC)  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Retinal detachment  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Ocular/visual - other  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Ocular surface disease  1  1/133 (0.75%)  1 2/129 (1.55%)  2 0/29 (0.00%)  0
Keratitis (corneal inflammation/corneal ulceration)  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Vision-photophobia  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Optic disc edema  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  9/133 (6.77%)  11 15/129 (11.63%)  19 0/29 (0.00%)  0
Pain, throat/pharynx/larynx  1  0/133 (0.00%)  0 2/129 (1.55%)  3 0/29 (0.00%)  0
Mucositis/stomatitis (clinical exam), oral cavity  1  5/133 (3.76%)  6 1/129 (0.78%)  1 0/29 (0.00%)  0
Diarrhea  1  7/133 (5.26%)  7 14/129 (10.85%)  17 0/29 (0.00%)  0
Typhlitis (cecal inflammation)  1  6/133 (4.51%)  6 4/129 (3.10%)  4 0/29 (0.00%)  0
Vomiting  1  7/133 (5.26%)  8 16/129 (12.40%)  18 0/29 (0.00%)  0
Colitis  1  6/133 (4.51%)  6 5/129 (3.88%)  5 0/29 (0.00%)  0
Hemorrhage, GI, Oral cavity  1  1/133 (0.75%)  1 3/129 (2.33%)  4 0/29 (0.00%)  0
Pain, Abdomen NOS  1  4/133 (3.01%)  6 5/129 (3.88%)  6 0/29 (0.00%)  0
Pain, Anus  1  0/133 (0.00%)  0 4/129 (3.10%)  5 0/29 (0.00%)  0
Gastrointestinal - Other  1  1/133 (0.75%)  1 2/129 (1.55%)  3 0/29 (0.00%)  0
Heartburn/dyspepsia  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)  1  2/133 (1.50%)  2 2/129 (1.55%)  2 0/29 (0.00%)  0
Proctitis  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Obstruction, GI, Sotmach  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Distension/bloating, abdominal  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Enteritis (inflammation of the small bowel)  1  3/133 (2.26%)  3 0/129 (0.00%)  0 0/29 (0.00%)  0
Esophagitis  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
Hemorrhage, GI, Lower GI NOS  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Mucositis/stomatitis (functional/symptomatic), oral cavity  1  4/133 (3.01%)  4 0/129 (0.00%)  0 0/29 (0.00%)  0
Pain, rectum  1  5/133 (3.76%)  5 1/129 (0.78%)  1 0/29 (0.00%)  0
Perforation, GI, appendix  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Dysphagia (difficulty swallowing)  1  2/133 (1.50%)  2 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, oral cavity  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, dental/teeth/peridontal  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Hemorrhage, GI, abdomen NOS  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Gastritis (including bile reflux gastritis)  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
Pain, stomach  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Mucositis/stomatitis (clinical exam), small bowel  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Mucotitis/stomatitis (functional/symptomatic), esophagus  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Incontinence, anal  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, lip  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
General disorders       
Death not associated with CTCAE term, multi-organ failure  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Constitutional symptoms - other  1  1/133 (0.75%)  2 2/129 (1.55%)  3 0/29 (0.00%)  0
Weight loss  1  3/133 (2.26%)  4 3/129 (2.33%)  5 0/29 (0.00%)  0
Injection site reaction/extravasation changes  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
Pain - other  1  1/133 (0.75%)  2 1/129 (0.78%)  1 0/29 (0.00%)  0
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)  1  10/133 (7.52%)  10 6/129 (4.65%)  6 0/29 (0.00%)  0
Edema: head and neck  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Death not associated with CTCAE term, sudden death  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Hepatobiliary disorders       
Liver dysfunction/failure (clinical)  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Hepatobiliary/pancreas - other  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Cholecystitis  1  3/133 (2.26%)  3 0/129 (0.00%)  0 0/29 (0.00%)  0
Immune system disorders       
Allergic reaction/hypersensitivity (including drug fever)  1  11/133 (8.27%)  13 8/129 (6.20%)  8 0/29 (0.00%)  0
Allergy/immunology - other  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Allergic reaction to Asparaginase  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Infections and infestations       
Infection (documented clinically or microbiologically documented, ANC<1.0x10e9/L, fever>38.5C),blood  1  20/133 (15.04%)  23 21/129 (16.28%)  24 0/29 (0.00%)  0
Infection (documented clinically or microbioogically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)  1  71/133 (53.38%)  103 77/129 (59.69%)  115 0/29 (0.00%)  0
Infection - other  1  2/133 (1.50%)  2 4/129 (3.10%)  4 0/29 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils  1  7/133 (5.26%)  7 15/129 (11.63%)  16 0/29 (0.00%)  0
Colitis, infectious (e.g., Clostridium difficile)  1  21/133 (15.79%)  25 18/129 (13.95%)  18 0/29 (0.00%)  0
Infection with unknown ANC, blood  1  3/133 (2.26%)  3 3/129 (2.33%)  3 0/29 (0.00%)  0
Infection with unknown ANC, lung (pneumonia)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Infection with unknown ANC, urinary tract NOS  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Infection with unknown ANC, catheter-related  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Infection with unknown ANC, lip/perioral  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Injury, poisoning and procedural complications       
Intra-operative injury - other  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Thrombosis/embolism (vascular access-related  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Investigations       
PTT (Partial Thromboplastin Time)  1  2/133 (1.50%)  2 4/129 (3.10%)  4 0/29 (0.00%)  0
INR (International Normalized Ratio of prothrombin time)  1  1/133 (0.75%)  1 2/129 (1.55%)  2 0/29 (0.00%)  0
Metabolism and nutrition disorders       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  33/133 (24.81%)  47 48/129 (37.21%)  62 0/29 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  45/133 (33.83%)  78 48/129 (37.21%)  90 0/29 (0.00%)  0
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  20/133 (15.04%)  26 27/129 (20.93%)  35 0/29 (0.00%)  0
Acidosis (metabolic or respiratory)  1  4/133 (3.01%)  5 4/129 (3.10%)  4 0/29 (0.00%)  0
Allbumin, serum-low (hypoalbuminemia)  1  7/133 (5.26%)  10 4/129 (3.10%)  6 0/29 (0.00%)  0
Alkalosis (metabolic or respiratory)  1  2/133 (1.50%)  2 1/129 (0.78%)  1 0/29 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  7/133 (5.26%)  7 11/129 (8.53%)  15 0/29 (0.00%)  0
Glucose, serum-high (hyperglycemia)  1  16/133 (12.03%)  19 14/129 (10.85%)  15 0/29 (0.00%)  0
Sodium, serum-high (hypernatremia)  1  4/133 (3.01%)  4 1/129 (0.78%)  1 0/29 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  8/133 (6.02%)  8 8/129 (6.20%)  10 0/29 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  16/133 (12.03%)  20 14/129 (10.85%)  16 0/29 (0.00%)  0
Lipase  1  1/133 (0.75%)  1 4/129 (3.10%)  4 0/29 (0.00%)  0
Alkaline phosphatase  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Anorexia  1  11/133 (8.27%)  12 13/129 (10.08%)  18 0/29 (0.00%)  0
GGT (gamma-Glutamyl transpeptidase)  1  2/133 (1.50%)  2 5/129 (3.88%)  5 0/29 (0.00%)  0
Magnesium, serum-high (hypermagnesemia)  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Potassium, serum-ghigh (hyperkalemia)  1  2/133 (1.50%)  3 5/129 (3.88%)  9 0/29 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  17/133 (12.78%)  22 10/129 (7.75%)  14 0/29 (0.00%)  0
Dehydration  1  1/133 (0.75%)  1 6/129 (4.65%)  6 0/29 (0.00%)  0
Amylase  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Tumor lysis syndrome  1  7/133 (5.26%)  7 7/129 (5.43%)  7 0/29 (0.00%)  0
Uric acid, serum-high (hyperuricemia)  1  3/133 (2.26%)  3 1/129 (0.78%)  1 0/29 (0.00%)  0
Bicarbonate, serum-low  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Glucose, serum-low (hypoglycemia)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Fibrinogen  1  1/133 (0.75%)  1 2/129 (1.55%)  2 0/29 (0.00%)  0
Creatinine  1  1/133 (0.75%)  1 3/129 (2.33%)  3 0/29 (0.00%)  0
Metabolic/Laboratory  1  2/133 (1.50%)  2 2/129 (1.55%)  2 0/29 (0.00%)  0
Magnesium, serum-low (hypomagnesemia)  1  2/133 (1.50%)  2 2/129 (1.55%)  2 0/29 (0.00%)  0
Calcium, serum-high (hypercalcemia)  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain, back  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, extremity-limb  1  1/133 (0.75%)  1 2/129 (1.55%)  3 0/29 (0.00%)  0
Pain, buttock  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, muscle  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Pain, joint  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Musculoskeletal/soft tissue - other  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Growth and development - other  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, chest wall  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Muscle weakness, generalized or specific area (not due to neuropathy), extremity-upper  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Nervous system disorders       
Syncope (fainting)  1  2/133 (1.50%)  2 4/129 (3.10%)  4 0/29 (0.00%)  0
Pain, head/headache  1  4/133 (3.01%)  4 3/129 (2.33%)  5 0/29 (0.00%)  0
Neuropathy: sensory  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Hydrocephalus  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Encephalopathy  1  2/133 (1.50%)  2 3/129 (2.33%)  3 0/29 (0.00%)  0
Hemorrhage, CNS  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Neuropathy: cranial, CN VI lateral deviation of eye  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Neuropathy: motor  1  3/133 (2.26%)  3 2/129 (1.55%)  2 0/29 (0.00%)  0
Seizure  1  1/133 (0.75%)  1 3/129 (2.33%)  3 0/29 (0.00%)  0
Ataxia (incoordination)  1  4/133 (3.01%)  4 0/129 (0.00%)  0 0/29 (0.00%)  0
Speech impairment (e.g., dysphasia or aphasia)  1  5/133 (3.76%)  5 0/129 (0.00%)  0 0/29 (0.00%)  0
CNS cerebrovascular ischemia  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
CNS necrosis/cystic progression  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Somnolence/depressed level of consciousness  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Neurology - other  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Neuropathy: cranial, CN IX Motor-pharynx; sensory-ear, pharynx, tongue  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Vasovagal episode  1  0/133 (0.00%)  0 1/129 (0.78%)  2 0/29 (0.00%)  0
Psychiatric disorders       
Mood alteration, anxiety  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Mood alteration, depression  1  0/133 (0.00%)  0 1/129 (0.78%)  2 0/29 (0.00%)  0
Personality/behavioral  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Mood alteration, agitation  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Mood alteration, euphoria  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Confusion  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
Renal and urinary disorders       
Renal failure  1  3/133 (2.26%)  4 3/129 (2.33%)  3 0/29 (0.00%)  0
Cystitis  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Glomerular filtration rate  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Urinary frequency/urgency  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Renal/genitourinary - other  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Incontinence, urinary  1  0/133 (0.00%)  0 1/129 (0.78%)  2 0/29 (0.00%)  0
Urinary retention (including neurogenic bladder)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Reproductive system and breast disorders       
Pain, vagina  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Hemorrhage, GU, iuterus  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Hypoxia  1  10/133 (7.52%)  10 19/129 (14.73%)  20 0/29 (0.00%)  0
Pulmonary/upper respiratory - other  1  3/133 (2.26%)  3 3/129 (2.33%)  3 0/29 (0.00%)  0
Dyspnea (shortness of breath)  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  2/133 (1.50%)  2 0/129 (0.00%)  0 0/29 (0.00%)  0
Pleural effusion (non-malignant)  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Adult Respiratory Distress Syndrome (ARDS)  1  2/133 (1.50%)  2 4/129 (3.10%)  4 0/29 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory, nose  1  3/133 (2.26%)  4 6/129 (4.65%)  6 0/29 (0.00%)  0
Aspiration  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Apnea  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Atelectasis  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Hiccoughs (hiccups, singultus)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash/desquamation  1  7/133 (5.26%)  8 3/129 (2.33%)  3 0/29 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Dermatology/skin - other  1  0/133 (0.00%)  0 2/129 (1.55%)  2 0/29 (0.00%)  0
Rash: acne/acneiform  1  1/133 (0.75%)  1 0/129 (0.00%)  0 0/29 (0.00%)  0
Rash: hand-foot skin reaction  1  0/133 (0.00%)  0 4/129 (3.10%)  4 0/29 (0.00%)  0
Pruritus/itching  1  1/133 (0.75%)  1 1/129 (0.78%)  1 0/29 (0.00%)  0
Pain, skin  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  0/133 (0.00%)  0 0/129 (0.00%)  0 0/29 (0.00%)  0
Vascular disorders       
Hemorrhage/bleeding - other  1  0/133 (0.00%)  0 1/129 (0.78%)  1 0/29 (0.00%)  0
Hypertension  1  10/133 (7.52%)  12 5/129 (3.88%)  5 0/29 (0.00%)  0
Hypotension  1  8/133 (6.02%)  9 9/129 (6.98%)  9 0/29 (0.00%)  0
Thrombosis/thrombus/embolism  1  3/133 (2.26%)  3 1/129 (0.78%)  1 0/29 (0.00%)  0
Acute vascular leak syndrome  1  1/133 (0.75%)  1 3/129 (2.33%)  3 0/29 (0.00%)  0
Hematoma  1  3/133 (2.26%)  4 0/129 (0.00%)  0 0/29 (0.00%)  0
1
Term from vocabulary, CTCAE v. 3.0
Indicates events were collected by systematic assessment
[1]
ANC <1.0x10e9/L, fever >=38.5C
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cytarabine+Daunorubicin+Etoposide Clofarabine+Cytarabine Stem Cell Donors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/133 (6.77%)      9/129 (6.98%)      0/29 (0.00%)    
Immune system disorders       
Allergic reaction/hypersensitivity (including drug fever)  1  9/133 (6.77%)  11 9/129 (6.98%)  10 0/29 (0.00%)  0
1
Term from vocabulary, CTCAE v. 3.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey E. Rubnitz, MD, PhD
Organization: St. Jude Children's Research Hospital
Phone: 901-595-2388
EMail: jeffrey.rubnitz@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00703820     History of Changes
Other Study ID Numbers: AML08
R01CA138744 ( U.S. NIH Grant/Contract )
R01CA115422 ( U.S. NIH Grant/Contract )
R01CA132946 ( U.S. NIH Grant/Contract )
NCI-2011-03659 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: March 2, 2018
Results First Posted: April 2, 2018
Last Update Posted: May 6, 2019