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Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01522976
First received: January 27, 2012
Last updated: July 26, 2016
Last verified: April 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Chronic Myelomonocytic Leukemia-1
Chronic Myelomonocytic Leukemia-2
Previously Treated Myelodysplastic Syndrome
Refractory Anemia With Excess Blasts
Interventions: Drug: Azacitidine
Drug: Lenalidomide
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
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 1: Azacitidine/Lenalidomide

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Arm 2: Azacitidine

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Arm 3: Azacitidine/Vorinostat

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO


Participant Flow:   Overall Study
    Arm 1: Azacitidine/Lenalidomide     Arm 2: Azacitidine     Arm 3: Azacitidine/Vorinostat  
STARTED     97     92     93  
COMPLETED     0     0     0  
NOT COMPLETED     97     92     93  
Ineligible                 4                 0                 1  
Death                 7                 6                 2  
Still on treatment                 9                 9                 6  
Disease progression                 28                 30                 25  
Adverse Event                 17                 7                 18  
Refusal unrelated to adverse event                 10                 13                 14  
Not protocol specified                 22                 27                 27  



  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.
Analysis includes eligible patients only.

Reporting Groups
  Description
Arm 1: Azacitidine/Lenalidomide

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Lenalidomide: Given PO

Arm 2: Azacitidine

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Arm 3: Azacitidine/Vorinostat

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC or IV

Vorinostat: Given PO

Total Total of all reporting groups

Baseline Measures
    Arm 1: Azacitidine/Lenalidomide     Arm 2: Azacitidine     Arm 3: Azacitidine/Vorinostat     Total  
Number of Participants  
[units: participants]
  93     92     92     277  
Age  
[units: years]
Median (Full Range)
  70.81  
  (51.29 to 86.68)  
  69.67  
  (42.69 to 88.96)  
  70.36  
  (28.69 to 93.01)  
  70.18  
  (28.69 to 93.01)  
Gender  
[units: participants]
       
Female     32     31     22     85  
Male     61     61     70     192  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     1     0     1     2  
Asian     1     4     2     7  
Native Hawaiian or Other Pacific Islander     0     0     1     1  
Black or African American     2     3     4     9  
White     86     80     83     249  
More than one race     0     0     0     0  
Unknown or Not Reported     3     5     1     9  



  Outcome Measures
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1.  Primary:   Response Rate (Phase II)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Relapse-free Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

4.  Secondary:   Pre-study Cytogenetic Abnormalities   [ Time Frame: Up to 5 years ]

5.  Secondary:   Toxicity Rate   [ Time Frame: Up to 5 years ]

6.  Primary:   Overall Survival (Phase III)   [ Time Frame: Up to 5 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: Leukemia Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-6597
e-mail: amoseley@fredhutch.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01522976     History of Changes
Other Study ID Numbers: NCI-2012-00242
NCI-2012-00242 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S1117
CDR0000723909
S1117 ( Other Identifier: SWOG )
S1117 ( Other Identifier: CTEP )
U10CA180888 ( US NIH Grant/Contract Award Number )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: January 27, 2012
Results First Received: February 18, 2016
Last Updated: July 26, 2016
Health Authority: United States: Food and Drug Administration