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Vorinostat in Treating Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00305773
First received: March 21, 2006
Last updated: April 30, 2014
Last verified: December 2012
Results First Received: March 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Acute Erythroid Leukemia (M6)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Refractory Cytopenia With Multilineage Dysplasia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Intervention: Drug: vorinostat

  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
A total of 37 participants were enrolled into this trial between January 2006 and August 2007. One patient on Arm A was ineligible; this participant was included in all analyses.

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 (Once Daily Vorinostat) Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Arm B (Thrice Daily Vorinostat) Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm A (Once Daily Vorinostat)     Arm B (Thrice Daily Vorinostat)  
STARTED     15     22  
COMPLETED     1     4  
NOT COMPLETED     14     18  
Death                 3                 2  
Adverse Event                 1                 2  
Alternative Treatment                 4                 4  
Physician Decision                 1                 1  
Withdrawal by Subject                 1                 4  
Disease Progression                 1                 3  
All other reasons                 3                 2  



  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 (Once Daily Vorinostat) Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Arm B (Thrice Daily Vorinostat) Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Arm A (Once Daily Vorinostat)     Arm B (Thrice Daily Vorinostat)     Total  
Number of Participants  
[units: participants]
  15     22     37  
Age  
[units: years]
Median ( Full Range )
  67  
  ( 41 to 79 )  
  67  
  ( 28 to 81 )  
  67  
  ( 28 to 81 )  
Gender  
[units: participants]
     
Female     5     5     10  
Male     10     17     27  
Region of Enrollment  
[units: participants]
     
United States     15     22     37  
Disease status  
[units: participants]
     
Relapsed     12     16     28  
Untreated     3     6     9  
AML disease classification  
[units: participants]
     
Relapsed AML with good risk cytogenetics     0     0     0  
All other relapsed AML     12     16     28  
Untreated AML patients >= 65 years old     3     3     6  
Untreated AML patients with MDS-AML     0     3     3  
Untreated AML with >= 3 cytogenetic abnnormalities     0     0     0  



  Outcome Measures
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1.  Primary:   Confirmed Complete Response (CR) Rate   [ Time Frame: Up to 2 years ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Duration of study (up to 2 years) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Duration of study (up to 2 years) ]

4.  Secondary:   Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events   [ Time Frame: Duration of study (up to 2 years) ]

5.  Other Pre-specified:   Time to Treatment Failure (TTF)   [ Time Frame: Duration of treatment (up to 17 cycles) ]


  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 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: Steven Gore, MD
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
e-mail: gorest@jhmi.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305773     History of Changes
Other Study ID Numbers: NCI-2012-01470, NCI-2012-01470, CDR0000465213, JHOC-J0557, MAYO-MC0483, JHOC-J0550, NCI-6882, MC0483, 6882, N01CM62205, P30CA015083
Study First Received: March 21, 2006
Results First Received: March 28, 2013
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration