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Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT01272245
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Omacetaxine
Drug: Cytarabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 7/14/2011through 1/9/2015. All participants recruited at The University of Texas MD Anderson Cancer Center.

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
Omacetaxine and Cytarabine Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.

Participant Flow:   Overall Study
    Omacetaxine and Cytarabine
STARTED   36 
COMPLETED   36 
NOT COMPLETED   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
Omacetaxine and Cytarabine Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.

Baseline Measures
   Omacetaxine and Cytarabine 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Years]
Median (Full Range)
 71 
 (60 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      17  47.2% 
Male      19  52.8% 
Region of Enrollment 
[Units: Count of Participants]
 
United States   36 


  Outcome Measures

1.  Primary:   Percentage of Participants With Complete Remission (CR)   [ Time Frame: Up to 4 months ]

2.  Secondary:   Evaluation of CR Duration   [ Time Frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication. ]

3.  Secondary:   Disease-free Survival   [ Time Frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication. ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication. ]

5.  Secondary:   Induction Mortality   [ Time Frame: Up to 1 year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kantarjian,Hagop M
Organization: UT MD Anderson Cancer Center
phone: 713-792-7026
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01272245     History of Changes
Other Study ID Numbers: 2010-0736
NCI-2013-02220 ( Registry Identifier: NCI CTRP )
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: March 19, 2018
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018