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Trial record 68 of 91 for:    gemtuzumab ozogamicin

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid 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: NCT00372593
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : January 13, 2015
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride
Enrollment 1070
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Period Title: Overall Study
Started 531 532 7
Completed 327 334 3
Not Completed 204 198 4
Reason Not Completed
Adverse Event             43             45             0
Death             16             20             1
Lack of Efficacy             82             71             2
Lost to Follow-up             1             0             0
Physician Decision             42             41             0
Ineligible             20             21             1
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome Total
Hide Arm/Group Description Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Total of all reporting groups
Overall Number of Baseline Participants 531 532 7 1070
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
3352.86  (2336.55) 3466  (2283.45) 4206.71  (1979.95) 3409.43  (2310)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
<=18 years
516
  97.2%
510
  95.9%
7
 100.0%
1033
  96.5%
Between 18 and 65 years
15
   2.8%
22
   4.1%
0
   0.0%
37
   3.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
Female
260
  49.0%
277
  52.1%
4
  57.1%
541
  50.6%
Male
271
  51.0%
255
  47.9%
3
  42.9%
529
  49.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
American Indian or Alaska Native
3
   0.6%
1
   0.2%
0
   0.0%
4
   0.4%
Asian
28
   5.3%
24
   4.5%
0
   0.0%
52
   4.9%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
0
   0.0%
2
   0.2%
Black or African American
62
  11.7%
58
  10.9%
2
  28.6%
122
  11.4%
White
383
  72.1%
394
  74.1%
5
  71.4%
782
  73.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
54
  10.2%
54
  10.2%
0
   0.0%
108
  10.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
Hispanic or Latino
100
  18.8%
97
  18.2%
0
   0.0%
197
  18.4%
Not Hispanic or Latino
411
  77.4%
416
  78.2%
7
 100.0%
834
  77.9%
Unknown or Not Reported
20
   3.8%
19
   3.6%
0
   0.0%
39
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 531 participants 532 participants 7 participants 1070 participants
United States 473 480 5 958
Canada 34 32 2 68
Australia 19 15 0 34
Switzerland 1 0 0 1
New Zealand 4 5 0 9
1.Primary Outcome
Title Event-free Survival at 3 Years
Hide Description The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.
Time Frame Time from study entry to time of induction failure, relapse, or death, assessed at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 511 511 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.9
(42.5 to 51.3)
53.1
(48.6 to 57.4)
50.0
(11.1 to 80.4)
2.Primary Outcome
Title Overall Survival at 3 Years
Hide Description The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.
Time Frame Time from study entry, assessed at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 511 511 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.4
(61.0 to 69.4)
69.4
(65.1 to 73.3)
50.0
(11.1 to 80.4)
3.Secondary Outcome
Title Remission Induction Rate After 2 Courses of Induction Therapy
Hide Description Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.
Time Frame After 2 courses of induction (I and II) therapy, assessed for up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45).
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 491 486 6
Measure Type: Number
Unit of Measure: Proportion of participants
0.851324 0.882716 0.666667
4.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description Time from end of Intensification I to relapse, death or last contact
Time Frame At 3 years from end of Intensification I
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247).
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 377 400 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage participants DFS at 3 years
56.6
(51.3 to 61.5)
63.0
(58.0 to 67.5)
75.0
(12.8 to 96.1)
5.Secondary Outcome
Title Mortality
Hide Description Number of participants who died during the first three courses of therapy.
Time Frame During the first three courses of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible (n=42) patients are excluded.
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 511 511 6
Measure Type: Number
Unit of Measure: Number of participants
11 13 1
6.Secondary Outcome
Title Time to Marrow Recovery
Hide Description Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.
Time Frame At 25 days after treatment with Induction I, Induction II, and Intensification I
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 511 511 6
Mean (Standard Deviation)
Unit of Measure: Mean days
During Induction I (days 0 - 28 of therapy) Number Analyzed 380 participants 391 participants 6 participants
30.56  (6.96) 30.56  (6.47) 29.17  (2.79)
During Induction II (days 29 - 56 of therapy) Number Analyzed 394 participants 405 participants 5 participants
28.54  (6.69) 28.52  (6.25) 26.6  (4.83)
During Intensification I (days 57 - 84 of therapy) Number Analyzed 355 participants 383 participants 4 participants
27.51  (5.95) 28.10  (6.32) 24.5  (3.70)
7.Secondary Outcome
Title Toxicities, Including Infectious Complications
Hide Description Number of participants with at least one grade 3 or higher adverse event during therapy.
Time Frame From the time therapy is initiated, assessed up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible (n=42) patients are excluded.
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description:
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Overall Number of Participants Analyzed 511 511 6
Measure Type: Number
Unit of Measure: Number of participants
482 477 5
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
 
Arm/Group Title Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Hide Arm/Group Description Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
All-Cause Mortality
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/511 (5.09%)   32/511 (6.26%)   2/6 (33.33%) 
Blood and lymphatic system disorders       
Disseminated intravascular coagulation  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Febrile neutropenia  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Cardiac disorders       
Atrial flutter  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Cardiac disorders - Other  3/511 (0.59%)  4/511 (0.78%)  0/6 (0.00%) 
Heart failure  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Left ventricular systolic dysfunction  2/511 (0.39%)  5/511 (0.98%)  0/6 (0.00%) 
Pericardial effusion  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Pericarditis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Restrictive cardiomyopathy  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Right ventricular dysfunction  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Ascites  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Gastritis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Mucositis oral  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
General disorders       
Death NOS  3/511 (0.59%)  3/511 (0.59%)  1/6 (16.67%) 
Multi-organ failure  6/511 (1.17%)  2/511 (0.39%)  0/6 (0.00%) 
Sudden death NOS  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Hepatobiliary disorders       
Hepatic failure  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Portal hypertension  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Infections and infestations       
Enterocolitis infectious  0/511 (0.00%)  0/511 (0.00%)  1/6 (16.67%) 
Infections and infestations - Other  14/511 (2.74%)  15/511 (2.94%)  1/6 (16.67%) 
Lung infection  0/511 (0.00%)  0/511 (0.00%)  1/6 (16.67%) 
Sepsis  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Investigations       
Alanine aminotransferase increased  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Aspartate aminotransferase increased  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Blood bilirubin increased  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Creatinine increased  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Electrocardiogram QT corrected interval prolonged  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Fibrinogen decreased  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Investigations - Other  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Lipase increased  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Serum amylase increased  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Acidosis  3/511 (0.59%)  3/511 (0.59%)  0/6 (0.00%) 
Hyperglycemia  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Hyperkalemia  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Hypocalcemia  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Hypoglycemia  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Hypokalemia  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Hyponatremia  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Nervous system disorders       
Encephalopathy  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Intracranial hemorrhage  0/511 (0.00%)  6/511 (1.17%)  0/6 (0.00%) 
Nervous system disorders - Other  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Seizure  1/511 (0.20%)  1/511 (0.20%)  1/6 (16.67%) 
Psychiatric disorders       
Confusion  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  8/511 (1.57%)  2/511 (0.39%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  4/511 (0.78%)  8/511 (1.57%)  0/6 (0.00%) 
Atelectasis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Bronchopulmonary hemorrhage  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Bronchospasm  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Dyspnea  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Hypoxia  7/511 (1.37%)  7/511 (1.37%)  2/6 (33.33%) 
Pleural effusion  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Pleural hemorrhage  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Pneumonitis  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Vascular disorders       
Hypotension  6/511 (1.17%)  4/511 (0.78%)  1/6 (16.67%) 
Vascular disorders - Other  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   482/511 (94.32%)   479/511 (93.74%)   5/6 (83.33%) 
Blood and lymphatic system disorders       
Anemia  10/511 (1.96%)  8/511 (1.57%)  0/6 (0.00%) 
Blood and lymphatic system disorders - Other  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Disseminated intravascular coagulation  8/511 (1.57%)  13/511 (2.54%)  0/6 (0.00%) 
Febrile neutropenia  267/511 (52.25%)  280/511 (54.79%)  4/6 (66.67%) 
Cardiac disorders       
Cardiac arrest  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Cardiac disorders - Other  110/511 (21.53%)  95/511 (18.59%)  1/6 (16.67%) 
Heart failure  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Left ventricular systolic dysfunction  32/511 (6.26%)  21/511 (4.11%)  0/6 (0.00%) 
Myocarditis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Paroxysmal atrial tachycardia  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Pericardial effusion  8/511 (1.57%)  4/511 (0.78%)  1/6 (16.67%) 
Pericarditis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Restrictive cardiomyopathy  4/511 (0.78%)  1/511 (0.20%)  0/6 (0.00%) 
Right ventricular dysfunction  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Sinus bradycardia  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Sinus tachycardia  6/511 (1.17%)  10/511 (1.96%)  0/6 (0.00%) 
Supraventricular tachycardia  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Ventricular tachycardia  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Ear and labyrinth disorders       
Ear pain  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
External ear pain  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Hearing impaired  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Middle ear inflammation  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Tinnitus  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Endocrine disorders - Other  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Eye disorders       
Blurred vision  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Conjunctivitis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Eye disorders - Other  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Eye pain  1/511 (0.20%)  5/511 (0.98%)  0/6 (0.00%) 
Photophobia  3/511 (0.59%)  4/511 (0.78%)  0/6 (0.00%) 
Uveitis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Vitreous hemorrhage  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  3/511 (0.59%)  4/511 (0.78%)  0/6 (0.00%) 
Abdominal pain  38/511 (7.44%)  44/511 (8.61%)  0/6 (0.00%) 
Anal mucositis  5/511 (0.98%)  3/511 (0.59%)  0/6 (0.00%) 
Anal pain  7/511 (1.37%)  7/511 (1.37%)  0/6 (0.00%) 
Anal ulcer  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Ascites  18/511 (3.52%)  19/511 (3.72%)  0/6 (0.00%) 
Cheilitis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Colitis  18/511 (3.52%)  9/511 (1.76%)  0/6 (0.00%) 
Colonic fistula  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Colonic hemorrhage  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Constipation  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Dental caries  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Diarrhea  80/511 (15.66%)  58/511 (11.35%)  1/6 (16.67%) 
Duodenal hemorrhage  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Dyspepsia  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Dysphagia  4/511 (0.78%)  3/511 (0.59%)  0/6 (0.00%) 
Enterocolitis  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Esophageal hemorrhage  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Esophageal pain  3/511 (0.59%)  2/511 (0.39%)  0/6 (0.00%) 
Esophagitis  12/511 (2.35%)  12/511 (2.35%)  0/6 (0.00%) 
Gastric hemorrhage  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Gastritis  9/511 (1.76%)  3/511 (0.59%)  0/6 (0.00%) 
Gastrointestinal disorders - Other  3/511 (0.59%)  8/511 (1.57%)  0/6 (0.00%) 
Gastrointestinal pain  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Gingival pain  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Hemorrhoids  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Ileus  7/511 (1.37%)  9/511 (1.76%)  0/6 (0.00%) 
Intra-abdominal hemorrhage  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Lip pain  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Lower gastrointestinal hemorrhage  4/511 (0.78%)  5/511 (0.98%)  0/6 (0.00%) 
Malabsorption  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Mucositis oral  82/511 (16.05%)  94/511 (18.40%)  2/6 (33.33%) 
Nausea  49/511 (9.59%)  62/511 (12.13%)  1/6 (16.67%) 
Oral hemorrhage  3/511 (0.59%)  1/511 (0.20%)  0/6 (0.00%) 
Oral pain  28/511 (5.48%)  35/511 (6.85%)  0/6 (0.00%) 
Pancreatitis  4/511 (0.78%)  3/511 (0.59%)  0/6 (0.00%) 
Proctitis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Rectal fistula  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Rectal hemorrhage  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Rectal mucositis  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Rectal pain  14/511 (2.74%)  9/511 (1.76%)  0/6 (0.00%) 
Small intestinal mucositis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Small intestinal obstruction  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Stomach pain  3/511 (0.59%)  0/511 (0.00%)  0/6 (0.00%) 
Toothache  3/511 (0.59%)  1/511 (0.20%)  0/6 (0.00%) 
Typhlitis  29/511 (5.68%)  31/511 (6.07%)  0/6 (0.00%) 
Upper gastrointestinal hemorrhage  1/511 (0.20%)  3/511 (0.59%)  0/6 (0.00%) 
Vomiting  34/511 (6.65%)  44/511 (8.61%)  0/6 (0.00%) 
General disorders       
Chills  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Death NOS  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Edema face  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Edema limbs  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Edema trunk  3/511 (0.59%)  1/511 (0.20%)  0/6 (0.00%) 
Facial pain  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Fatigue  7/511 (1.37%)  4/511 (0.78%)  0/6 (0.00%) 
Fever  26/511 (5.09%)  21/511 (4.11%)  0/6 (0.00%) 
General disorders and administration site conditions - Other  9/511 (1.76%)  2/511 (0.39%)  0/6 (0.00%) 
Localized edema  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Multi-organ failure  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Non-cardiac chest pain  7/511 (1.37%)  6/511 (1.17%)  0/6 (0.00%) 
Pain  15/511 (2.94%)  20/511 (3.91%)  0/6 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  4/511 (0.78%)  2/511 (0.39%)  0/6 (0.00%) 
Gallbladder necrosis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Gallbladder obstruction  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Gallbladder pain  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Hepatic failure  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Hepatic pain  13/511 (2.54%)  16/511 (3.13%)  0/6 (0.00%) 
Hepatobiliary disorders - Other  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Portal hypertension  7/511 (1.37%)  6/511 (1.17%)  0/6 (0.00%) 
Immune system disorders       
Allergic reaction  0/511 (0.00%)  0/511 (0.00%)  1/6 (16.67%) 
Anaphylaxis  25/511 (4.89%)  32/511 (6.26%)  1/6 (16.67%) 
Cytokine release syndrome  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Immune system disorders - Other  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Infections and infestations       
Abdominal infection  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Anorectal infection  0/511 (0.00%)  4/511 (0.78%)  0/6 (0.00%) 
Appendicitis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Bladder infection  6/511 (1.17%)  4/511 (0.78%)  0/6 (0.00%) 
Bone infection  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Bronchial infection  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Catheter related infection  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Enterocolitis infectious  20/511 (3.91%)  19/511 (3.72%)  0/6 (0.00%) 
Eye infection  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Gallbladder infection  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Gum infection  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Infections and infestations - Other  395/511 (77.30%)  406/511 (79.45%)  4/6 (66.67%) 
Infective myositis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Kidney infection  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Lip infection  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Lung infection  12/511 (2.35%)  9/511 (1.76%)  0/6 (0.00%) 
Lymph gland infection  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Meningitis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Mucosal infection  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Otitis media  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Penile infection  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Pharyngitis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Rhinitis infective  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Scrotal infection  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Sepsis  4/511 (0.78%)  8/511 (1.57%)  0/6 (0.00%) 
Sinusitis  1/511 (0.20%)  3/511 (0.59%)  0/6 (0.00%) 
Skin infection  10/511 (1.96%)  7/511 (1.37%)  0/6 (0.00%) 
Small intestine infection  3/511 (0.59%)  2/511 (0.39%)  0/6 (0.00%) 
Soft tissue infection  2/511 (0.39%)  7/511 (1.37%)  0/6 (0.00%) 
Tooth infection  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Tracheitis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Upper respiratory infection  5/511 (0.98%)  8/511 (1.57%)  0/6 (0.00%) 
Urinary tract infection  11/511 (2.15%)  8/511 (1.57%)  0/6 (0.00%) 
Vaginal infection  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Vulval infection  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Wound infection  4/511 (0.78%)  4/511 (0.78%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Burn  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Fracture  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Injury, poisoning and procedural complications - Other  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Intraoperative gastrointestinal injury  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Intraoperative respiratory injury  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Postoperative hemorrhage  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Tracheal hemorrhage  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Vascular access complication  5/511 (0.98%)  5/511 (0.98%)  0/6 (0.00%) 
Venous injury  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Investigations       
Activated partial thromboplastin time prolonged  13/511 (2.54%)  15/511 (2.94%)  0/6 (0.00%) 
Alanine aminotransferase increased  84/511 (16.44%)  103/511 (20.16%)  0/6 (0.00%) 
Alkaline phosphatase increased  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Aspartate aminotransferase increased  55/511 (10.76%)  73/511 (14.29%)  0/6 (0.00%) 
Blood bilirubin increased  57/511 (11.15%)  61/511 (11.94%)  0/6 (0.00%) 
Cardiac troponin T increased  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
CPK increased  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Creatinine increased  13/511 (2.54%)  9/511 (1.76%)  0/6 (0.00%) 
Electrocardiogram QT corrected interval prolonged  69/511 (13.50%)  68/511 (13.31%)  0/6 (0.00%) 
Fibrinogen decreased  7/511 (1.37%)  3/511 (0.59%)  0/6 (0.00%) 
GGT increased  25/511 (4.89%)  41/511 (8.02%)  0/6 (0.00%) 
INR increased  5/511 (0.98%)  5/511 (0.98%)  0/6 (0.00%) 
Investigations - Other  5/511 (0.98%)  0/511 (0.00%)  0/6 (0.00%) 
Lipase increased  27/511 (5.28%)  21/511 (4.11%)  0/6 (0.00%) 
Neutrophil count decreased  15/511 (2.94%)  11/511 (2.15%)  0/6 (0.00%) 
Platelet count decreased  13/511 (2.54%)  12/511 (2.35%)  0/6 (0.00%) 
Serum amylase increased  16/511 (3.13%)  8/511 (1.57%)  0/6 (0.00%) 
Weight gain  16/511 (3.13%)  16/511 (3.13%)  0/6 (0.00%) 
Weight loss  21/511 (4.11%)  12/511 (2.35%)  0/6 (0.00%) 
White blood cell decreased  11/511 (2.15%)  8/511 (1.57%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Acidosis  7/511 (1.37%)  13/511 (2.54%)  0/6 (0.00%) 
Alkalosis  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Anorexia  144/511 (28.18%)  165/511 (32.29%)  2/6 (33.33%) 
Dehydration  16/511 (3.13%)  16/511 (3.13%)  0/6 (0.00%) 
Glucose intolerance  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Hypercalcemia  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Hyperglycemia  117/511 (22.90%)  124/511 (24.27%)  1/6 (16.67%) 
Hyperkalemia  25/511 (4.89%)  39/511 (7.63%)  1/6 (16.67%) 
Hypermagnesemia  5/511 (0.98%)  14/511 (2.74%)  0/6 (0.00%) 
Hypernatremia  7/511 (1.37%)  16/511 (3.13%)  1/6 (16.67%) 
Hypertriglyceridemia  3/511 (0.59%)  6/511 (1.17%)  0/6 (0.00%) 
Hyperuricemia  2/511 (0.39%)  7/511 (1.37%)  0/6 (0.00%) 
Hypoalbuminemia  24/511 (4.70%)  24/511 (4.70%)  0/6 (0.00%) 
Hypocalcemia  56/511 (10.96%)  44/511 (8.61%)  1/6 (16.67%) 
Hypoglycemia  3/511 (0.59%)  4/511 (0.78%)  0/6 (0.00%) 
Hypokalemia  169/511 (33.07%)  191/511 (37.38%)  1/6 (16.67%) 
Hypomagnesemia  17/511 (3.33%)  9/511 (1.76%)  0/6 (0.00%) 
Hyponatremia  59/511 (11.55%)  63/511 (12.33%)  1/6 (16.67%) 
Hypophosphatemia  43/511 (8.41%)  58/511 (11.35%)  0/6 (0.00%) 
Tumor lysis syndrome  9/511 (1.76%)  9/511 (1.76%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  3/511 (0.59%)  2/511 (0.39%)  0/6 (0.00%) 
Arthritis  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Avascular necrosis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Back pain  14/511 (2.74%)  11/511 (2.15%)  0/6 (0.00%) 
Bone pain  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Buttock pain  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Chest wall pain  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Generalized muscle weakness  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Joint effusion  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Muscle weakness left-sided  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorder - Other  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Myalgia  1/511 (0.20%)  6/511 (1.17%)  0/6 (0.00%) 
Myositis  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Neck pain  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Pain in extremity  12/511 (2.35%)  15/511 (2.94%)  0/6 (0.00%) 
Nervous system disorders       
Abducens nerve disorder  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Arachnoiditis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Ataxia  3/511 (0.59%)  0/511 (0.00%)  0/6 (0.00%) 
Depressed level of consciousness  3/511 (0.59%)  4/511 (0.78%)  0/6 (0.00%) 
Dizziness  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Encephalopathy  5/511 (0.98%)  5/511 (0.98%)  0/6 (0.00%) 
Facial nerve disorder  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Headache  19/511 (3.72%)  28/511 (5.48%)  0/6 (0.00%) 
Hydrocephalus  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Intracranial hemorrhage  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Nervous system disorders - Other  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Neuralgia  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Oculomotor nerve disorder  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Peripheral motor neuropathy  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Peripheral sensory neuropathy  3/511 (0.59%)  6/511 (1.17%)  0/6 (0.00%) 
Seizure  7/511 (1.37%)  5/511 (0.98%)  0/6 (0.00%) 
Syncope  5/511 (0.98%)  9/511 (1.76%)  0/6 (0.00%) 
Psychiatric disorders       
Agitation  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Anxiety  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Confusion  4/511 (0.78%)  4/511 (0.78%)  0/6 (0.00%) 
Depression  6/511 (1.17%)  3/511 (0.59%)  0/6 (0.00%) 
Euphoria  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Insomnia  3/511 (0.59%)  0/511 (0.00%)  0/6 (0.00%) 
Personality change  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Psychosis  6/511 (1.17%)  3/511 (0.59%)  0/6 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  9/511 (1.76%)  25/511 (4.89%)  1/6 (16.67%) 
Chronic kidney disease  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Cystitis noninfective  1/511 (0.20%)  5/511 (0.98%)  0/6 (0.00%) 
Hematuria  3/511 (0.59%)  6/511 (1.17%)  0/6 (0.00%) 
Proteinuria  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Renal and urinary disorders - Other  3/511 (0.59%)  3/511 (0.59%)  0/6 (0.00%) 
Urinary frequency  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Urinary tract obstruction  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Urinary tract pain  2/511 (0.39%)  1/511 (0.20%)  0/6 (0.00%) 
Reproductive system and breast disorders       
Pelvic pain  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Penile pain  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Perineal pain  2/511 (0.39%)  3/511 (0.59%)  0/6 (0.00%) 
Uterine hemorrhage  2/511 (0.39%)  6/511 (1.17%)  0/6 (0.00%) 
Uterine pain  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Vaginal hemorrhage  1/511 (0.20%)  6/511 (1.17%)  0/6 (0.00%) 
Vaginal pain  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  21/511 (4.11%)  37/511 (7.24%)  0/6 (0.00%) 
Apnea  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Aspiration  2/511 (0.39%)  2/511 (0.39%)  0/6 (0.00%) 
Atelectasis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Bronchopulmonary hemorrhage  2/511 (0.39%)  5/511 (0.98%)  0/6 (0.00%) 
Bronchospasm  1/511 (0.20%)  4/511 (0.78%)  0/6 (0.00%) 
Cough  6/511 (1.17%)  6/511 (1.17%)  0/6 (0.00%) 
Dyspnea  22/511 (4.31%)  24/511 (4.70%)  0/6 (0.00%) 
Epistaxis  16/511 (3.13%)  23/511 (4.50%)  0/6 (0.00%) 
Hypoxia  77/511 (15.07%)  84/511 (16.44%)  1/6 (16.67%) 
Laryngeal edema  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Pharyngeal hemorrhage  2/511 (0.39%)  0/511 (0.00%)  0/6 (0.00%) 
Pharyngeal mucositis  5/511 (0.98%)  5/511 (0.98%)  0/6 (0.00%) 
Pharyngeal stenosis  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Pharyngolaryngeal pain  6/511 (1.17%)  8/511 (1.57%)  0/6 (0.00%) 
Pleural effusion  19/511 (3.72%)  16/511 (3.13%)  0/6 (0.00%) 
Pleuritic pain  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Pneumonitis  39/511 (7.63%)  29/511 (5.68%)  0/6 (0.00%) 
Pneumothorax  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Pulmonary hypertension  4/511 (0.78%)  3/511 (0.59%)  0/6 (0.00%) 
Respiratory failure  1/511 (0.20%)  0/511 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other  7/511 (1.37%)  5/511 (0.98%)  0/6 (0.00%) 
Sinus disorder  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythema multiforme  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Pain of skin  2/511 (0.39%)  4/511 (0.78%)  0/6 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Pruritus  5/511 (0.98%)  4/511 (0.78%)  0/6 (0.00%) 
Purpura  0/511 (0.00%)  1/511 (0.20%)  0/6 (0.00%) 
Rash maculo-papular  25/511 (4.89%)  29/511 (5.68%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other  3/511 (0.59%)  5/511 (0.98%)  0/6 (0.00%) 
Skin induration  0/511 (0.00%)  2/511 (0.39%)  0/6 (0.00%) 
Skin ulceration  3/511 (0.59%)  3/511 (0.59%)  0/6 (0.00%) 
Stevens-Johnson syndrome  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
Urticaria  3/511 (0.59%)  2/511 (0.39%)  0/6 (0.00%) 
Vascular disorders       
Capillary leak syndrome  0/511 (0.00%)  3/511 (0.59%)  0/6 (0.00%) 
Hematoma  1/511 (0.20%)  2/511 (0.39%)  0/6 (0.00%) 
Hypertension  22/511 (4.31%)  38/511 (7.44%)  0/6 (0.00%) 
Hypotension  80/511 (15.66%)  79/511 (15.46%)  3/6 (50.00%) 
Thromboembolic event  3/511 (0.59%)  9/511 (1.76%)  0/6 (0.00%) 
Vascular disorders - Other  5/511 (0.98%)  5/511 (0.98%)  0/6 (0.00%) 
Vasculitis  1/511 (0.20%)  1/511 (0.20%)  0/6 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00372593     History of Changes
Other Study ID Numbers: AAML0531
COG-AAML0531 ( Other Identifier: Children's Oncology Group )
CDR0000487497 ( Other Identifier: Clinical Trials.gov )
First Submitted: September 6, 2006
First Posted: September 7, 2006
Results First Submitted: January 6, 2015
Results First Posted: January 13, 2015
Last Update Posted: April 28, 2017