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Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

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ClinicalTrials.gov Identifier: NCT00136084
Recruitment Status : Completed
First Posted : August 26, 2005
Results First Posted : March 26, 2010
Last Update Posted : December 5, 2012
Sponsor:
Collaborator:
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 Leukemia, Myelocytic, Acute
Interventions Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
Drug: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine
Enrollment 238
Recruitment Details 238 patients were recruited between October, 2002 and June, 2008.
Pre-assignment Details 238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.
Arm/Group Title Arm 1: (HDAC) Arm 2:(LDAC)
Hide Arm/Group Description High-dose Cytarabine (HDAC) Low-dose Cytarabine (LDAC)
Period Title: Overall Study
Started 109 114
Completed 61 72
Not Completed 48 42
Reason Not Completed
Death             12             5
Unacceptable toxicity             8             11
Relapse             20             23
Lost to Follow-up             2             0
No Response             1             2
Withdrawal by Subject             5             1
Arm/Group Title Arm 1: (HDAC) Arm 2:(LDAC) Total
Hide Arm/Group Description High-dose Cytarabine (HDAC) Low-dose Cytarabine (LDAC) Total of all reporting groups
Overall Number of Baseline Participants 109 114 223
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 114 participants 223 participants
8.57  (6.08) 8.48  (6.32) 8.49  (6.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 114 participants 223 participants
Female
50
  45.9%
48
  42.1%
98
  43.9%
Male
59
  54.1%
66
  57.9%
125
  56.1%
1.Primary Outcome
Title Minimal Residual Disease (MRD).
Hide Description Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).
Time Frame Day 22 MRD measurement
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.
Arm/Group Title Arm 1: (HDAC) Arm 2:(LDAC)
Hide Arm/Group Description:
High-dose Cytarabine (HDAC)
Low-dose Cytarabine (LDAC)
Overall Number of Participants Analyzed 99 106
Measure Type: Number
Unit of Measure: participants
MRD Positive 31 43
MRD Negative 68 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: (HDAC), Arm 2:(LDAC)
Comments The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O’Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .1559
Comments The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 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 a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.624
Confidence Interval 95%
.832 to 3.205
Estimation Comments The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.
2.Secondary Outcome
Title Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
Hide Description To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)
Time Frame Consolidation I
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.
Arm/Group Title Overall
Hide Arm/Group Description:
Post-GO Treatment MRD
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
Negative 11
Positive 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments Estimate of the proportion of negative minimal residual disease.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial proportion
Estimated Value .733
Confidence Interval 95%
.449 to .922
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
Hide Description To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.
Time Frame Induction II
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.
Arm/Group Title Overall
Hide Arm/Group Description:
Patients who have no response to one course of induction therapy
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Participants
Decrease 27
Increase or no change 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial proportion
Estimated Value .931
Confidence Interval 95%
.772 to .992
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
Hide Description To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy
Time Frame Induction II
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.
Arm/Group Title Overall
Hide Arm/Group Description:
Post-GO Treatment MRD
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Experienced Grade 3 or 4 toxicities 27
Did not experience Grade 3 or 4 toxicities 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial proportion
Estimated Value .9
Confidence Interval 95%
.735 to .979
Estimation Comments [Not Specified]
5.Secondary Outcome
Title To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
Hide Description Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up
Time Frame Five Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.
Arm/Group Title Overall
Hide Arm/Group Description:
Evaluation of all study participants
Overall Number of Participants Analyzed 216
Measure Type: Number
Unit of Measure: Percentage of Participants
62.4
6.Secondary Outcome
Title To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
Hide Description Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.
Time Frame Measurements were assessed in Induction I chemotherapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.
Arm/Group Title Arm 1: (HDAC) Arm 2:(LDAC)
Hide Arm/Group Description:
High-dose Cytarabine (Ara-C) (HDAC)
Low-dose Cytarabine (Ara-C) (LDAC)
Overall Number of Participants Analyzed 9 12
Mean (Standard Error)
Unit of Measure: Percent Inhibition of DNA Synthesis
60.6  (16.0) 72.8  (15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: (HDAC), Arm 2:(LDAC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Relationship of Inhibition of DNA Synthesis and Clinical Response
Hide Description Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.
Time Frame Measurements were assessed in Induction I chemotherapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.
Arm/Group Title Overall
Hide Arm/Group Description:
17 of the 232 eligible patients
Overall Number of Participants Analyzed 17
Mean (Standard Error)
Unit of Measure: Percent inhibition of DNA Synthesis
66.7  (12.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2287
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value -0.0139
Confidence Interval (2-Sided) 95%
-0.0365 to 0.00873
Estimation Comments [Not Specified]
Time Frame Adverse events have been collected from study inception (October, 2002) through February, 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: (HDAC) Arm 2:(LDAC)
Hide Arm/Group Description High-dose Cytarabine (HDAC) Low-dose Cytarabine (LDAC)
All-Cause Mortality
Arm 1: (HDAC) Arm 2:(LDAC)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: (HDAC) Arm 2:(LDAC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/109 (21.10%)      19/114 (16.67%)    
Blood and lymphatic system disorders     
DIC (disseminated intravascular coagulation * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Hemorrhage-Other * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Hemorrhage/bleeding associated with surgery * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Cardiac disorders     
Acute vascular leak syndrome * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Cardiac left ventricular function * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Cardiovascular/Arrhythmia-Other * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hypertension * 1  0/109 (0.00%)  0 0/114 (0.00%)  0
Hypotension * 1  2/109 (1.83%)  2 0/114 (0.00%)  0
Peripheral arterial ischemia * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Sinus tachycardia * 1  0/109 (0.00%)  0 2/114 (1.75%)  2
Thrombosis/embolism * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Gastrointestinal disorders     
Anorexia * 1  5/109 (4.59%)  8 3/114 (2.63%)  3
Diarrhea patients without colostomy * 1  0/109 (0.00%)  0 2/114 (1.75%)  2
Gastritis * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Pancreatitis * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Typhlitis (inflammation of cecum) * 1  0/109 (0.00%)  0 2/114 (1.75%)  2
Vomiting * 1  0/109 (0.00%)  0 2/114 (1.75%)  2
Hepatobiliary disorders     
Liver dysfunction/failure (clinical) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
SGOT (AST) (serum glutamic oxaloacetic transaminase) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
SGPT (ALT) (serum glutamic pyruvic transaminase) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Infections and infestations     
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  1/109 (0.92%)  1 4/114 (3.51%)  7
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e * 1  13/109 (11.93%)  19 10/114 (8.77%)  15
Infection with unknown ANC * 1  0/109 (0.00%)  0 1/114 (0.88%)  3
Infection without neutropenia * 1  1/109 (0.92%)  1/114 (0.88%)  1
Infection/Febrile Neutropenia-Other * 1  0/109 (0.00%)  0 1/114 (0.88%)  3
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hyperglycemia * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Hyperkalemia * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hypernatremia * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Hypocalcemia * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hypokalemia * 1  6/109 (5.50%)  8 4/114 (3.51%)  4
Lipase * 1  2/109 (1.83%)  2 0/114 (0.00%)  0
Nervous system disorders     
Arachnoiditis/meningismus/radiculitis * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
CNS cerebrovascular ischemia * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
CNS hemorrhage/bleeding * 1  0/109 (0.00%)  0 2/114 (1.75%)  4
Confusion * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Depressed level of consciousness * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hallucinations * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
Seizure(s) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Renal and urinary disorders     
Renal failure * 1  3/109 (2.75%)  3 0/114 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome (ARDS) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Dyspnea (shortness of breath) * 1  1/109 (0.92%)  1 0/114 (0.00%)  0
Hypoxia * 1  1/109 (0.92%)  1 1/114 (0.88%)  1
Pneumonitis/pulmonary infiltrates * 1  3/109 (2.75%)  4 0/114 (0.00%)  0
Pulmonary-Other * 1  0/109 (0.00%)  0 3/114 (2.63%)  3
Skin and subcutaneous tissue disorders     
Wound-infectious * 1  1/109 (0.92%)  1 1/114 (0.88%)  1
Vascular disorders     
Veno-Occlusive Dease (VOD) * 1  0/109 (0.00%)  0 1/114 (0.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: (HDAC) Arm 2:(LDAC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/109 (98.17%)      112/114 (98.25%)    
Blood and lymphatic system disorders     
DIC (disseminated intravascular coagulation) * 1  6/109 (5.50%)  6 0/114 (0.00%)  0
Epistaxis * 1  7/109 (6.42%)  9 9/114 (7.89%)  14
Hemorrhage-Other * 1  0/109 (0.00%)  0 12/114 (10.53%)  14
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia * 1  0/109 (0.00%)  0 6/114 (5.26%)  6
Cardiac disorders     
Hypertension * 1  8/109 (7.34%)  9 7/114 (6.14%)  9
Hypotension * 1  11/109 (10.09%)  14 20/114 (17.54%)  21
Eye disorders     
Conjunctivitis * 1  7/109 (6.42%)  7 0/114 (0.00%)  0
Gastrointestinal disorders     
Anorexia * 1  23/109 (21.10%)  28 16/114 (14.04%)  26
Colitis * 1  6/109 (5.50%)  7 0/114 (0.00%)  0
Dehydration * 1  0/109 (0.00%)  0 6/114 (5.26%)  6
Diarrhea patients without colostomy * 1  21/109 (19.27%)  26 20/114 (17.54%)  27
Gastrointestinal-Other * 1  8/109 (7.34%)  8 0/114 (0.00%)  0
Nausea * 1  6/109 (5.50%)  6 8/114 (7.02%)  11
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1  15/109 (13.76%)  18 19/114 (16.67%)  22
Typhlitis (inflammation of cecum) * 1  8/109 (7.34%)  10 16/114 (14.04%)  17
Vomiting * 1  14/109 (12.84%)  15 15/114 (13.16%)  20
General disorders     
Abdominal pain or cramping * 1  11/109 (10.09%)  12 0/114 (0.00%)  0
Headache * 1  6/109 (5.50%)  7 9/114 (7.89%)  11
Pain-Other * 1  6/109 (5.50%)  6 0/114 (0.00%)  0
Hepatobiliary disorders     
Bilirubin * 1  7/109 (6.42%)  8 0/114 (0.00%)  0
GGT (Gamma-Glutamyl transpeptidase) * 1  14/109 (12.84%)  21 8/114 (7.02%)  9
SGOT (AST) (serum glutamic oxaloacetic transaminase) * 1  10/109 (9.17%)  10 0/114 (0.00%)  0
SGPT (ALT) (serum glutamic pyruvic transaminase) * 1  18/109 (16.51%)  21 8/114 (7.02%)  9
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever) * 1  17/109 (15.60%)  19 16/114 (14.04%)  19
Infections and infestations     
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  69/109 (63.30%)  138 92/114 (80.70%)  181
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  0/109 (0.00%)  0 8/114 (7.02%)  9
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e * 1  83/109 (76.15%)  193 82/114 (71.93%)  178
Infection without neutropenia * 1  10/109 (9.17%)  10 13/114 (11.40%)  15
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory) * 1  6/109 (5.50%)  8 0/114 (0.00%)  0
Hyperglycemia * 1  15/109 (13.76%)  21 10/114 (8.77%)  13
Hyperkalemia * 1  7/109 (6.42%)  8 6/114 (5.26%)  14
Hypocalcemia * 1  12/109 (11.01%)  13 12/114 (10.53%)  17
Hypokalemia * 1  37/109 (33.94%)  79 38/114 (33.33%)  84
Hypomagnesmia * 1  8/109 (7.34%)  9 7/114 (6.14%)  11
Hyponatremia * 1  6/109 (5.50%)  8 9/114 (7.89%)  11
Hypophosphatemia * 1  12/109 (11.01%)  14 12/114 (10.53%)  14
Lipase * 1  6/109 (5.50%)  7 0/114 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  19/109 (17.43%)  20 17/114 (14.91%)  19
Pleural effusion (non-malignant) * 1  0/109 (0.00%)  0 7/114 (6.14%)  7
Pneumonitis/pulmonary infiltrates * 1  10/109 (9.17%)  12 0/114 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash/desquamation * 1  0/109 (0.00%)  0 8/114 (7.02%)  9
Wound-infectious * 1  0/109 (0.00%)  0 11/114 (9.65%)  12
Wound-non-infectious * 1  9/109 (8.26%)  10 6/114 (5.26%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jeffrey Rubnitz, M.D
Organization: St. Jude Children's Research Hospital
Phone: 1-866-278-5833
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00136084     History of Changes
Other Study ID Numbers: AML02
5R01CA113482 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2005
First Posted: August 26, 2005
Results First Submitted: March 5, 2010
Results First Posted: March 26, 2010
Last Update Posted: December 5, 2012