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Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01238211
First received: November 9, 2010
Last updated: July 21, 2014
Last verified: February 2014
Results First Received: July 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: dasatinib

  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
Between April 2011 and January 2013, 61 participants were recruited.

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
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)

INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.

CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.


Participant Flow:   Overall Study
    Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)  
STARTED     61  
COMPLETED     3  
NOT COMPLETED     58  
Continues active treatment                 31  
Adverse Event                 7  
Death                 4  
Relapse/Progression                 2  
Withdrawal by Subject                 7  
Non-protocol treatment                 4  
Investigator/Patient Decision                 3  



  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
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)

INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.

CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.


Baseline Measures
    Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)  
Number of Participants  
[units: participants]
  61  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 19.8 to 85 )  
Gender  
[units: participants]
 
Female     30  
Male     31  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     54  
Unknown or Not Reported     7  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     5  
White     46  
More than one race     0  
Unknown or Not Reported     8  
Region of Enrollment  
[units: participants]
 
United States     61  



  Outcome Measures

1.  Primary:   30 Day Survival Rate   [ Time Frame: 30 days ]

2.  Secondary:   Event-free Survival   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Complete Response Rate   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Cumulative Incidence of Relapse   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Cumulative Incidence of Death   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Disease-free Survival   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Overall Survival   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Guido Marcucci, M.D.
Organization: The Ohio State University
e-mail: Guido.Marcucci@osumc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01238211     History of Changes
Other Study ID Numbers: NCI-2011-02615, NCI-2011-02615, CALGB-10801, CDR0000688434, CALGB 10801, CALGB-10801, P30CA014236, U10CA031946
Study First Received: November 9, 2010
Results First Received: July 21, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration