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Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00313586
First received: April 11, 2006
Last updated: March 16, 2016
Last verified: January 2016
Results First Received: November 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
Alkylating Agent-Related Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Azacitidine
Drug: Entinostat
Other: Laboratory Biomarker Analysis

  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
Participants were recruited from ECOG member institutions between August 18, 2006 and April 29, 2011. One hundred and fifty non-treatment-induced patients and forty-seven treatment-induced patients were enrolled.

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 (Azacitidine; Non-treatment-induced Cohort) Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
Arm A (Azacitidine; Treatment-induced Cohort) Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
Arm B (Azacitidine + Entinostat; Treatment-induced Cohort) Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.

Participant Flow:   Overall Study
    Arm A (Azacitidine; Non-treatment-induced Cohort)   Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)   Arm A (Azacitidine; Treatment-induced Cohort)   Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
STARTED   75   75   24   23 
Treated   74   75   24   23 
COMPLETED   5   5   0   0 
NOT COMPLETED   70   70   24   23 
Disease progression                14                19                10                3 
Adverse Event                12                18                3                10 
Death                11                8                1                7 
Withdrawal by Subject                13                6                6                2 
Alternative therapy                3                6                2                0 
Other complicating disease                2                2                0                0 
Did not achieve HI-major/better response                10                7                2                1 
Physician Decision                2                1                0                0 
Absolute neutrophil count not recovered                2                1                0                0 
Lost insurance                0                1                0                0 
Moved                0                1                0                0 
Death before starting treatment                1                0                0                0 



  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.
All treated patients were included in the analysis.

Reporting Groups
  Description
Arm A (Azacitidine; Non-treatment-induced Cohort) Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort) Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
Arm A (Azacitidine; Treatment-induced Cohort) Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
Arm B (Azacitidine + Entinostat; Treatment-induced Cohort) Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
Total Total of all reporting groups

Baseline Measures
   Arm A (Azacitidine; Non-treatment-induced Cohort)   Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)   Arm A (Azacitidine; Treatment-induced Cohort)   Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   75   24   23   196 
Age 
[Units: Years]
Median (Full Range)
 72 
 (25 to 87) 
 72 
 (30 to 86) 
 68 
 (54 to 83) 
 71 
 (39 to 81) 
 71 
 (25 to 87) 
Gender 
[Units: Participants]
         
Female   24   23   15   11   73 
Male   50   52   9   12   123 
Region of Enrollment 
[Units: Participants]
         
United States   74   75   24   23   196 


  Outcome Measures

1.  Primary:   Proportion of Patients With Clinical Response   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00313586     History of Changes
Other Study ID Numbers: NCI-2009-01077
NCI-2009-01077 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-E1905
CDR0000466186
E1905 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1905 ( Other Identifier: CTEP )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: April 11, 2006
Results First Received: November 18, 2014
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration