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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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  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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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
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Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications of Results:
Cripe LD, Li X, Litzow M, et al.: A randomized, placebo-controlled, double blind trial of the MDR modulator, zosuquidar, during conventional induction and post-remission therapy for Pts > 60 years of age with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): ECOG 3999. [Abstract] Blood 108 (11): A-423, 2006.

Publications automatically indexed to this study:


Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00046930     History of Changes
Obsolete Identifiers: NCT00046046
Other Study ID Numbers: CDR0000257122, E3999, U10CA021115
Study First Received: October 3, 2002
Results First Received: August 17, 2010
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration