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Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00372593
First received: September 6, 2006
Last updated: February 7, 2017
Last verified: February 2017
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome 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.
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome 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.
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome 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.

Participant Flow:   Overall Study
    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
STARTED   531   532   7 
COMPLETED   327   334   3 
NOT COMPLETED   204   198   4 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome 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.
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome 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.
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 531   532   7   1070 
Age 
[Units: Days]
Mean (Standard Deviation)
 3352.86  (2336.55)   3466  (2283.45)   4206.71  (1979.95)   3409.43  (2310) 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: 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 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-free Survival at 3 Years   [ Time Frame: Time from study entry to time of induction failure, relapse, or death, assessed at 3 years ]

2.  Primary:   Overall Survival at 3 Years   [ Time Frame: Time from study entry, assessed at 3 years ]

3.  Secondary:   Remission Induction Rate After 2 Courses of Induction Therapy   [ Time Frame: After 2 courses of induction (I and II) therapy, assessed for up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Disease-free Survival   [ Time Frame: Time from the end of course 3 (Intensification I) to death or relapse; assessed for up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Mortality   [ Time Frame: During the first three courses of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Time to Marrow Recovery   [ Time Frame: At 25 days after treatment with Induction I, Induction II, and Intensification I ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Toxicities, Including Infectious Complications   [ Time Frame: From the time therapy is initiated, assessed up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 )
Study First Received: September 6, 2006
Results First Received: January 6, 2015
Last Updated: February 7, 2017