Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( ChemGenex Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00114959
First received: June 20, 2005
Last updated: January 8, 2015
Last verified: January 2015
Results First Received: January 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myeloid Leukemia, Chronic
Myeloid Leukemia, Chronic, Accelerated-Phase
Blast Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Interventions: Drug: Homoharringtonine
Drug: Imatinib Mesylate

  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
Homoharringtonine + Imatinib Mesylate Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.

Participant Flow:   Overall Study
    Homoharringtonine + Imatinib Mesylate  
STARTED     15  
COMPLETED     7 [1]
NOT COMPLETED     8  
Lack of Efficacy                 6  
Physician Decision                 1  
Death                 1  
[1] protocol definition of completed study is having received >= 4 cycles of treatment



  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
Homoharringtonine + Imatinib Mesylate Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.

Baseline Measures
    Homoharringtonine + Imatinib Mesylate  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Median (Full Range)
  55  
  (21 to 76)  
Gender  
[units: participants]
 
Female     7  
Male     8  
Race/Ethnicity, Customized  
[units: participants]
 
Black     4  
Caucasian     10  
Hispanic     1  



  Outcome Measures
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1.  Primary:   Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response   [ Time Frame: up to month 4 ]

2.  Primary:   Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response   [ Time Frame: up to month 4 ]

3.  Primary:   Number of Participants With Adverse Experiences (AEs)   [ Time Frame: up to 3 years ]

4.  Secondary:   Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome   [ Time Frame: up to month 4 ]


  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
This study was intended to follow a Simon two stage design to test 18 patients in each stratum (chronic, accelerated and blast phase) for efficacy. Only 15 were enrolled, an insufficient number for a formal statistical analysis of efficacy.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com



Responsible Party: Teva Pharmaceutical Industries ( ChemGenex Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00114959     History of Changes
Other Study ID Numbers: CGX-635-CML-201
MDACC protocol #2005-0067 ( Other Identifier: M.D. Anderson Cancer Center )
Study First Received: June 20, 2005
Results First Received: January 8, 2015
Last Updated: January 8, 2015
Health Authority: United States: Food and Drug Administration