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Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been terminated.
(Sponsor withdrew support)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00814164
First received: December 23, 2008
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: May 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: clofarabine
Drug: daunorubicin hydrochloride
Genetic: cytogenetic analysis
Genetic: protein expression analysis
Other: immunologic technique
Other: pharmacological study

  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
Clorafarbine With Daunorubicin

Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.

clofarabine: IV

daunorubicin hydrochloride: IV

cytogenetic analysis: Correlative study

protein expression analysis: Correlative Study

immunologic technique: Correlative Study

pharmacological study: Correlative Study


Participant Flow:   Overall Study
    Clorafarbine With Daunorubicin  
STARTED     21  
COMPLETED     2  
NOT COMPLETED     19  
Progression                 7  
not stated                 7  
Death                 5  



  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.
All treated and eligible patients

Reporting Groups
  Description
Clorafarbine With Daunorubicin

Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.

clofarabine: IV

daunorubicin hydrochloride: IV

cytogenetic analysis: Correlative study

protein expression analysis: Correlative Study

immunologic technique: Correlative Study

pharmacological study: Correlative Study


Baseline Measures
    Clorafarbine With Daunorubicin  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean (Standard Deviation)
  70.6  (6.7)  
Gender  
[units: participants]
 
Female     12  
Male     9  



  Outcome Measures
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1.  Primary:   Complete Remission (CR)   [ Time Frame: 2 years ]

2.  Secondary:   Disease-free Survival   [ Time Frame: 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 4 years ]

4.  Secondary:   Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy   [ Time Frame: 4 years ]

5.  Secondary:   Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes   [ Time Frame: 4 years ]

6.  Secondary:   Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression   [ Time Frame: 4 years ]

7.  Secondary:   Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels   [ Time Frame: 4 years ]

8.  Secondary:   A Preliminary Relationship Between Treatment Outcome and Biologic Parameters   [ Time Frame: 4 years ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00814164     History of Changes
Other Study ID Numbers: CDR0000630678
RPCI-I-132208 ( Other Identifier: Roswell Park Cancer Institute )
Study First Received: December 23, 2008
Results First Received: May 18, 2016
Last Updated: July 7, 2016
Health Authority: United States: Institutional Review Board