Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 18 for:    "Acute Promyelocytic Leukemia" | "Methotrexate"

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00866918
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Acute Promyelocytic Leukemia (M3)
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions Drug: arsenic trioxide
Drug: mitoxantrone hydrochloride
Other: diagnostic laboratory biomarker analysis
Drug: idarubicin
Drug: tretinoin
Drug: cytarabine
Drug: mercaptopurine tablet
Drug: methotrexate
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description WBC<10,000/MicroLiter WBC>=10,000/MicroLiter
Period Title: Overall Study
Started 69 39
Completed 53 27
Not Completed 16 12
Reason Not Completed
Death             1             5
Lack of Efficacy             1             1
Physician Decision             10             2
Ineligible             2             4
Inevaluable- RQPCR negative at diagnosi             1             0
Secondary malignancy             1             0
Arm/Group Title Standard Risk High Risk Total
Hide Arm/Group Description WBC<10,000/MicroLiter WBC>=10,000/MicroLiter Total of all reporting groups
Overall Number of Baseline Participants 69 39 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
<=18 years
68
  98.6%
38
  97.4%
106
  98.1%
Between 18 and 65 years
1
   1.4%
1
   2.6%
2
   1.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 69 participants 39 participants 108 participants
4915.25  (1627.27) 4921.33  (1747.04) 4917.44  (1663.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
Female
37
  53.6%
25
  64.1%
62
  57.4%
Male
32
  46.4%
14
  35.9%
46
  42.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
Hispanic or Latino
16
  23.2%
7
  17.9%
23
  21.3%
Not Hispanic or Latino
51
  73.9%
31
  79.5%
82
  75.9%
Unknown or Not Reported
2
   2.9%
1
   2.6%
3
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
American Indian or Alaska Native
2
   2.9%
0
   0.0%
2
   1.9%
Asian
0
   0.0%
3
   7.7%
3
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  11.6%
4
  10.3%
12
  11.1%
White
52
  75.4%
30
  76.9%
82
  75.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
  10.1%
2
   5.1%
9
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
Canada 2 2 4
United States 67 37 104
1.Primary Outcome
Title Event-free Survival (EFS)
Hide Description EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.
Time Frame At 3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible and inevaluable patients are excluded from analyses of EFS.
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description:
WBC<10,000/MicroLiter
WBC>=10,000/MicroLiter
Overall Number of Participants Analyzed 66 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.4
(86.3 to 98.5)
82.9
(65.8 to 91.9)
2.Secondary Outcome
Title Hematologic Remission Rate
Hide Description Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.
Time Frame End of consolidation, course 1: up to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description:
WBC<10,000/MicroLiter
WBC>=10,000/MicroLiter
Overall Number of Participants Analyzed 63 34
Measure Type: Number
Unit of Measure: Proportion of participants
1.0000 0.8824
3.Secondary Outcome
Title Hematologic, Molecular, and Cytogenetic Remission Rate
Hide Description Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.
Time Frame End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description:
WBC<10,000/MicroLiter
WBC>=10,000/MicroLiter
Overall Number of Participants Analyzed 63 34
Measure Type: Number
Unit of Measure: Proportion of participants
0.8095 0.5882
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS - time from study entry to death.
Time Frame At 3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible and inevaluable patients are excluded from analyses of OS.
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description:
WBC<10,000/MicroLiter
WBC>=10,000/MicroLiter
Overall Number of Participants Analyzed 66 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.4
(89.6 to 99.8)
85.7
(69.0 to 93.8)
Time Frame [Not Specified]
Adverse Event Reporting Description Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
 
Arm/Group Title Standard Risk High Risk
Hide Arm/Group Description WBC<10,000/MicroLiter WBC>=10,000/MicroLiter
All-Cause Mortality
Standard Risk High Risk
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Risk High Risk
Affected / at Risk (%) Affected / at Risk (%)
Total   17/66 (25.76%)   14/35 (40.00%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation [1]  0/66 (0.00%)  1/35 (2.86%) 
Febrile neutropenia [1]  6/66 (9.09%)  1/35 (2.86%) 
Cardiac disorders     
Asystole [1]  0/66 (0.00%)  1/35 (2.86%) 
Sinus tachycardia [1]  0/66 (0.00%)  1/35 (2.86%) 
Gastrointestinal disorders     
Abdominal pain [1]  0/66 (0.00%)  1/35 (2.86%) 
Nausea [1]  1/66 (1.52%)  1/35 (2.86%) 
Vomiting [1]  1/66 (1.52%)  1/35 (2.86%) 
General disorders     
Fever [1]  0/66 (0.00%)  1/35 (2.86%) 
Multi-organ failure [1]  0/66 (0.00%)  2/35 (5.71%) 
Pain [1]  1/66 (1.52%)  0/35 (0.00%) 
Infections and infestations     
Bronchial infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Catheter related infection [1]  2/66 (3.03%)  3/35 (8.57%) 
Endocarditis infective [1]  0/66 (0.00%)  1/35 (2.86%) 
Infections and infestations - Other, specify [1]  4/66 (6.06%)  3/35 (8.57%) 
Sepsis [1]  2/66 (3.03%)  3/35 (8.57%) 
Skin infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Urinary tract infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Investigations     
Alanine aminotransferase increased [1]  1/66 (1.52%)  1/35 (2.86%) 
Aspartate aminotransferase increased [1]  1/66 (1.52%)  1/35 (2.86%) 
Blood bilirubin increased [1]  0/66 (0.00%)  1/35 (2.86%) 
INR increased [1]  0/66 (0.00%)  1/35 (2.86%) 
Neutrophil count decreased [1]  0/66 (0.00%)  1/35 (2.86%) 
Platelet count decreased [1]  0/66 (0.00%)  1/35 (2.86%) 
White blood cell decreased [1]  0/66 (0.00%)  1/35 (2.86%) 
Metabolism and nutrition disorders     
Acidosis [1]  0/66 (0.00%)  1/35 (2.86%) 
Anorexia [1]  1/66 (1.52%)  0/35 (0.00%) 
Dehydration [1]  1/66 (1.52%)  1/35 (2.86%) 
Hyperglycemia [1]  0/66 (0.00%)  1/35 (2.86%) 
Hyperkalemia [1]  0/66 (0.00%)  1/35 (2.86%) 
Hypocalcemia [1]  0/66 (0.00%)  1/35 (2.86%) 
Hypomagnesemia [1]  0/66 (0.00%)  1/35 (2.86%) 
Hyponatremia [1]  0/66 (0.00%)  1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy [1]  1/66 (1.52%)  0/35 (0.00%) 
Nervous system disorders     
Syncope [1]  0/66 (0.00%)  1/35 (2.86%) 
Psychiatric disorders     
Depression [1]  0/66 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome [1]  1/66 (1.52%)  2/35 (5.71%) 
Dyspnea [1]  0/66 (0.00%)  1/35 (2.86%) 
Respiratory failure [1]  1/66 (1.52%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular [1]  0/66 (0.00%)  1/35 (2.86%) 
Vascular disorders     
Hypotension [1]  3/66 (4.55%)  1/35 (2.86%) 
[1]
Adeers submitted
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Risk High Risk
Affected / at Risk (%) Affected / at Risk (%)
Total   61/66 (92.42%)   33/35 (94.29%) 
Blood and lymphatic system disorders     
Anemia [1]  1/66 (1.52%)  0/35 (0.00%) 
Blood and lymphatic system disorders - Other, specify [1]  2/66 (3.03%)  0/35 (0.00%) 
Disseminated intravascular coagulation [1]  4/66 (6.06%)  3/35 (8.57%) 
Febrile neutropenia [1]  29/66 (43.94%)  20/35 (57.14%) 
Cardiac disorders     
Cardiac disorders - Other, specify [1]  1/66 (1.52%)  2/35 (5.71%) 
Ventricular arrhythmia [1]  1/66 (1.52%)  1/35 (2.86%) 
Ventricular tachycardia [1]  0/66 (0.00%)  1/35 (2.86%) 
Ear and labyrinth disorders     
Ear pain [1]  1/66 (1.52%)  0/35 (0.00%) 
Eye disorders     
Eye disorders - Other, specify [1]  1/66 (1.52%)  1/35 (2.86%) 
Papilledema [1]  0/66 (0.00%)  1/35 (2.86%) 
Retinopathy [1]  0/66 (0.00%)  1/35 (2.86%) 
Vitreous hemorrhage [1]  2/66 (3.03%)  0/35 (0.00%) 
Gastrointestinal disorders     
Abdominal pain [1]  3/66 (4.55%)  4/35 (11.43%) 
Anal pain [1]  1/66 (1.52%)  1/35 (2.86%) 
Ascites [1]  1/66 (1.52%)  0/35 (0.00%) 
Colitis [1]  1/66 (1.52%)  1/35 (2.86%) 
Constipation [1]  2/66 (3.03%)  0/35 (0.00%) 
Diarrhea [1]  3/66 (4.55%)  2/35 (5.71%) 
Dysphagia [1]  1/66 (1.52%)  0/35 (0.00%) 
Enterocolitis [1]  1/66 (1.52%)  0/35 (0.00%) 
Esophageal pain [1]  0/66 (0.00%)  1/35 (2.86%) 
Esophageal ulcer [1]  0/66 (0.00%)  1/35 (2.86%) 
Esophagitis [1]  0/66 (0.00%)  2/35 (5.71%) 
Gastritis [1]  1/66 (1.52%)  0/35 (0.00%) 
Mucositis oral [1]  12/66 (18.18%)  7/35 (20.00%) 
Nausea [1]  6/66 (9.09%)  0/35 (0.00%) 
Oral hemorrhage [1]  1/66 (1.52%)  1/35 (2.86%) 
Oral pain [1]  3/66 (4.55%)  2/35 (5.71%) 
Pancreatitis [1]  3/66 (4.55%)  0/35 (0.00%) 
Rectal fistula [1]  1/66 (1.52%)  0/35 (0.00%) 
Rectal hemorrhage [1]  1/66 (1.52%)  0/35 (0.00%) 
Rectal pain [1]  1/66 (1.52%)  2/35 (5.71%) 
Toothache [1]  1/66 (1.52%)  0/35 (0.00%) 
Typhlitis [1]  2/66 (3.03%)  1/35 (2.86%) 
Vomiting [1]  6/66 (9.09%)  0/35 (0.00%) 
General disorders     
Fever [1]  6/66 (9.09%)  2/35 (5.71%) 
Pain [1]  1/66 (1.52%)  8/35 (22.86%) 
Hepatobiliary disorders     
Cholecystitis [1]  0/66 (0.00%)  1/35 (2.86%) 
Immune system disorders     
Allergic reaction [1]  1/66 (1.52%)  0/35 (0.00%) 
Infections and infestations     
Anorectal infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Appendicitis [1]  0/66 (0.00%)  1/35 (2.86%) 
Appendicitis perforated [1]  0/66 (0.00%)  1/35 (2.86%) 
Bone infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Bronchial infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Catheter related infection [1]  7/66 (10.61%)  4/35 (11.43%) 
Enterocolitis infectious [1]  3/66 (4.55%)  1/35 (2.86%) 
Esophageal infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Hepatic infection [1]  0/66 (0.00%)  1/35 (2.86%) 
Infections and infestations - Other, specify [1]  15/66 (22.73%)  15/35 (42.86%) 
Lip infection [1]  0/66 (0.00%)  2/35 (5.71%) 
Lung infection [1]  3/66 (4.55%)  6/35 (17.14%) 
Lymph gland infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Mucosal infection [1]  0/66 (0.00%)  1/35 (2.86%) 
Nail infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Otitis externa [1]  1/66 (1.52%)  0/35 (0.00%) 
Otitis media [1]  2/66 (3.03%)  1/35 (2.86%) 
Papulopustular rash [1]  1/66 (1.52%)  0/35 (0.00%) 
Pharyngitis [1]  1/66 (1.52%)  0/35 (0.00%) 
Sepsis [1]  1/66 (1.52%)  0/35 (0.00%) 
Sinusitis [1]  2/66 (3.03%)  1/35 (2.86%) 
Skin infection [1]  5/66 (7.58%)  1/35 (2.86%) 
Small intestine infection [1]  0/66 (0.00%)  1/35 (2.86%) 
Soft tissue infection [1]  2/66 (3.03%)  0/35 (0.00%) 
Splenic infection [1]  0/66 (0.00%)  1/35 (2.86%) 
Stoma site infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Tooth infection [1]  0/66 (0.00%)  1/35 (2.86%) 
Upper respiratory infection [1]  2/66 (3.03%)  3/35 (8.57%) 
Urinary tract infection [1]  3/66 (4.55%)  0/35 (0.00%) 
Vaginal infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Vulval infection [1]  1/66 (1.52%)  0/35 (0.00%) 
Wound infection [1]  2/66 (3.03%)  0/35 (0.00%) 
Injury, poisoning and procedural complications     
Vascular access complication [1]  0/66 (0.00%)  1/35 (2.86%) 
Investigations     
Activated partial thromboplastin time prolonged [1]  2/66 (3.03%)  2/35 (5.71%) 
Alanine aminotransferase increased [1]  14/66 (21.21%)  7/35 (20.00%) 
Alkaline phosphatase increased [1]  0/66 (0.00%)  2/35 (5.71%) 
Aspartate aminotransferase increased [1]  8/66 (12.12%)  2/35 (5.71%) 
Blood bilirubin increased [1]  5/66 (7.58%)  2/35 (5.71%) 
Creatinine increased [1]  0/66 (0.00%)  1/35 (2.86%) 
Electrocardiogram QT corrected interval prolonged [1]  16/66 (24.24%)  6/35 (17.14%) 
Fibrinogen decreased [1]  2/66 (3.03%)  2/35 (5.71%) 
GGT increased [1]  3/66 (4.55%)  0/35 (0.00%) 
Investigations - Other, specify [1]  0/66 (0.00%)  1/35 (2.86%) 
Lipase increased [1]  1/66 (1.52%)  0/35 (0.00%) 
Lymphocyte count decreased [1]  2/66 (3.03%)  1/35 (2.86%) 
Neutrophil count decreased [1]  4/66 (6.06%)  2/35 (5.71%) 
Platelet count decreased [1]  3/66 (4.55%)  0/35 (0.00%) 
Weight gain [1]  1/66 (1.52%)  0/35 (0.00%) 
Weight loss [1]  3/66 (4.55%)  0/35 (0.00%) 
White blood cell decreased [1]  3/66 (4.55%)  0/35 (0.00%) 
Metabolism and nutrition disorders     
Acidosis [1]  0/66 (0.00%)  1/35 (2.86%) 
Anorexia [1]  5/66 (7.58%)  5/35 (14.29%) 
Dehydration [1]  2/66 (3.03%)  1/35 (2.86%) 
Hypercalcemia [1]  1/66 (1.52%)  0/35 (0.00%) 
Hyperglycemia [1]  13/66 (19.70%)  4/35 (11.43%) 
Hyperkalemia [1]  2/66 (3.03%)  1/35 (2.86%) 
Hypernatremia [1]  2/66 (3.03%)  1/35 (2.86%) 
Hypertriglyceridemia [1]  1/66 (1.52%)  2/35 (5.71%) 
Hypocalcemia [1]  4/66 (6.06%)  2/35 (5.71%) 
Hypokalemia [1]  13/66 (19.70%)  9/35 (25.71%) 
Hyponatremia [1]  4/66 (6.06%)  2/35 (5.71%) 
Hypophosphatemia [1]  5/66 (7.58%)  3/35 (8.57%) 
Metabolism and nutrition disorders - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Tumor lysis syndrome [1]  0/66 (0.00%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders     
Back pain [1]  1/66 (1.52%)  0/35 (0.00%) 
Muscle weakness right-sided [1]  0/66 (0.00%)  1/35 (2.86%) 
Pain in extremity [1]  2/66 (3.03%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Nervous system disorders     
Arachnoiditis [1]  1/66 (1.52%)  0/35 (0.00%) 
Dysarthria [1]  1/66 (1.52%)  0/35 (0.00%) 
Headache [1]  16/66 (24.24%)  4/35 (11.43%) 
Intracranial hemorrhage [1]  0/66 (0.00%)  1/35 (2.86%) 
Nervous system disorders - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Psychiatric disorders     
Agitation [1]  1/66 (1.52%)  0/35 (0.00%) 
Depression [1]  1/66 (1.52%)  0/35 (0.00%) 
Insomnia [1]  0/66 (0.00%)  1/35 (2.86%) 
Suicide attempt [1]  1/66 (1.52%)  1/35 (2.86%) 
Renal and urinary disorders     
Acute kidney injury [1]  1/66 (1.52%)  2/35 (5.71%) 
Hematuria [1]  1/66 (1.52%)  0/35 (0.00%) 
Renal and urinary disorders - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome [1]  2/66 (3.03%)  1/35 (2.86%) 
Atelectasis [1]  0/66 (0.00%)  1/35 (2.86%) 
Bronchopulmonary hemorrhage [1]  3/66 (4.55%)  0/35 (0.00%) 
Bronchospasm [1]  1/66 (1.52%)  0/35 (0.00%) 
Dyspnea [1]  2/66 (3.03%)  2/35 (5.71%) 
Epistaxis [1]  3/66 (4.55%)  1/35 (2.86%) 
Hypoxia [1]  8/66 (12.12%)  3/35 (8.57%) 
Laryngeal mucositis [1]  1/66 (1.52%)  0/35 (0.00%) 
Laryngeal obstruction [1]  1/66 (1.52%)  0/35 (0.00%) 
Pleural effusion [1]  1/66 (1.52%)  3/35 (8.57%) 
Pleural hemorrhage [1]  1/66 (1.52%)  0/35 (0.00%) 
Pneumonitis [1]  2/66 (3.03%)  0/35 (0.00%) 
Pulmonary edema [1]  1/66 (1.52%)  1/35 (2.86%) 
Respiratory failure [1]  0/66 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders - Other, specify [1]  2/66 (3.03%)  0/35 (0.00%) 
Retinoic acid syndrome [1]  4/66 (6.06%)  1/35 (2.86%) 
Sore throat [1]  0/66 (0.00%)  2/35 (5.71%) 
Stridor [1]  1/66 (1.52%)  0/35 (0.00%) 
Tracheal stenosis [1]  1/66 (1.52%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Pain of skin [1]  1/66 (1.52%)  0/35 (0.00%) 
Rash maculo-papular [1]  1/66 (1.52%)  3/35 (8.57%) 
Skin and subcutaneous tissue disorders - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Skin ulceration [1]  0/66 (0.00%)  1/35 (2.86%) 
Surgical and medical procedures     
Surgical and medical procedures - Other, specify [1]  1/66 (1.52%)  0/35 (0.00%) 
Vascular disorders     
Hematoma [1]  1/66 (1.52%)  0/35 (0.00%) 
Hypertension [1]  3/66 (4.55%)  2/35 (5.71%) 
Hypotension [1]  4/66 (6.06%)  5/35 (14.29%) 
Thromboembolic event [1]  3/66 (4.55%)  1/35 (2.86%) 
[1]
Adeers not subm
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00866918     History of Changes
Other Study ID Numbers: AAML0631
NCI-2011-01904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000637184 ( Other Identifier: ClinicalTrials.gov )
AAML0631 ( Other Identifier: Children's Oncology Group )
AAML0631 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2009
First Posted: March 23, 2009
Results First Submitted: October 25, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017