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Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eli Lilly and Company
Kanisa Pharmaceuticals
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00046930
First received: October 3, 2002
Last updated: June 21, 2011
Last verified: December 2010
History of Changes
Results First Received: August 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Leukemia
Myelodysplastic Syndromes
Interventions: Biological: filgrastim
Biological: sargramostim
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: zosuquidar trihydrochloride
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Zosuquidar Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo Induction treatment with daunorubicin, cytarabine and placebo

Participant Flow:   Overall Study
    Zosuquidar     Placebo  
STARTED     224     225  
COMPLETED     212     221  
NOT COMPLETED     12     4  
Ineligible                 12                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Zosuquidar Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo Induction treatment with daunorubicin, cytarabine and placebo
Total Total of all reporting groups

Baseline Measures
    Zosuquidar     Placebo     Total  
Number of Participants  
[units: participants]
 		  212     221     433  
Age  
[units: years]
Mean ± Standard Deviation 		  69.4  ± 5.5     69.2  ± 5.3     69.3  ± 5.4  
Gender  
[units: participants]
 		     
Female     103     85     188  
Male     109     136     245  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]
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2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]
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3.  Secondary:   Response   [ Time Frame: Assessed at the end of induction ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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