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

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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

  Participant Flow

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
Standard Risk WBC<10,000/MicroLiter
High Risk WBC>=10,000/MicroLiter

Participant Flow:   Overall Study
    Standard Risk   High Risk
STARTED   69   39 
COMPLETED   53   27 
NOT COMPLETED   16   12 
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 



  Baseline Characteristics

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
Standard Risk WBC<10,000/MicroLiter
High Risk WBC>=10,000/MicroLiter
Total Total of all reporting groups

Baseline Measures
   Standard Risk   High Risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   39   108 
Age 
[Units: Participants]
Count of 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 
[Units: Days]
Mean (Standard Deviation)
 4915.25  (1627.27)   4921.33  (1747.04)   4917.44  (1663.37) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  53.6%      25  64.1%      62  57.4% 
Male      32  46.4%      14  35.9%      46  42.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
Canada   2   2   4 
United States   67   37   104 


  Outcome Measures

1.  Primary:   Event-free Survival (EFS)   [ Time Frame: At 3 years from study entry ]

2.  Secondary:   Hematologic Remission Rate   [ Time Frame: End of consolidation, course 1: up to 5 months ]

3.  Secondary:   Hematologic, Molecular, and Cytogenetic Remission Rate   [ 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) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: At 3 years from study entry ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



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