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Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101880
First Posted: April 12, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington
Results First Submitted: March 4, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Untreated Adult Acute Myeloid Leukemia
Myeloproliferative Neoplasm With 10% Blasts or Higher
Interventions: Biological: filgrastim
Drug: clofarabine
Drug: cytarabine

  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
Treatment (Chemotherapy and Colony Stimulating Factor)

INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.

CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.

Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.

filgrastim: Given SC

clofarabine: Given IV

cytarabine: Given IV


Participant Flow:   Overall Study
    Treatment (Chemotherapy and Colony Stimulating Factor)
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  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
Treatment (Chemotherapy and Colony Stimulating Factor)

INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.

CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.

Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.

filgrastim: Given SC

clofarabine: Given IV

cytarabine: Given IV


Baseline Measures
   Treatment (Chemotherapy and Colony Stimulating Factor) 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Median (Full Range)
 53 
 (22 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  46.0% 
Male      27  54.0% 
Cytogenetic Risk Factor 
[Units: Participants]
Count of Participants
 
Favorable      4   8.0% 
Intermediate      32  64.0% 
Unfavorable      13  26.0% 
Indeterminate      1   2.0% 
Antecedent hematological disorder (AHD) 
[Units: Participants]
Count of Participants
 23 
FLT3 ITD mutation status [1] 
[Units: Participants]
Count of Participants
 10 
[1] Number of participants with a FLT3 ITD mutation
WBC 
[Units: Cells x 10^9/L]
Median (Full Range)
 12 
 (0.8 to 761.3) 
Peripheral Blast 
[Units: Percent of white blood cells]
Median (Full Range)
 16 
 (0 to 100) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts   [ Time Frame: Up to 5 years ]

2.  Primary:   Duration of Remission   [ Time Frame: Up to 5 years ]

3.  Primary:   Time to Progression   [ Time Frame: Up to 5 years ]

4.  Primary:   Event Free Survival   [ Time Frame: Up to 5 years ]

5.  Primary:   Treatment-related Mortality (TRM)   [ Time Frame: Up to 5 years ]

6.  Primary:   Overall Survival   [ Time Frame: Up to 5 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:  
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.


Results Point of Contact:  
Name/Title: Pamela Becker, MD, PhD
Organization: University of Washington
phone: 206-288-7273
e-mail: pbecker@uw.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier: NCT01101880     History of Changes
Other Study ID Numbers: 7144
NCI-2010-00282 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 8, 2010
First Posted: April 12, 2010
Results First Submitted: March 4, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017