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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

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ClinicalTrials.gov Identifier: NCT01101880
Recruitment Status : Completed
First Posted : April 12, 2010
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington

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
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants
53
(22 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
23
  46.0%
Male
27
  54.0%
Cytogenetic Risk Factor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Favorable
4
   8.0%
Intermediate
32
  64.0%
Unfavorable
13
  26.0%
Indeterminate
1
   2.0%
Antecedent hematological disorder (AHD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
23
  46.0%
FLT3 ITD mutation status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
10
  20.0%
[1]
Measure Description: Number of participants with a FLT3 ITD mutation
WBC  
Median (Full Range)
Unit of measure:  Cells x 10^9/L
Number Analyzed 50 participants
12
(0.8 to 761.3)
Peripheral Blast  
Median (Full Range)
Unit of measure:  Percent of white blood cells
Number Analyzed 50 participants
16
(0 to 100)
1.Primary Outcome
Title Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts
Hide Description With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
CR achieved with no AHD only applies to those who did not have AHD.
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
CR achieved Number Analyzed 50 participants
38
  76.0%
CR achieved with first course of induction Number Analyzed 50 participants
33
  66.0%
CR + CRp achieved Number Analyzed 50 participants
41
  82.0%
CR achieved with no AHD Number Analyzed 27 participants
23
  85.2%
CR achieved with AHD Number Analyzed 23 participants
15
  65.2%
CR + CRp achieved with AHD Number Analyzed 23 participants
18
  78.3%
CR achieved with FLT3 positive Number Analyzed 10 participants
7
  70.0%
CR achieved with favorable risk cytogenetics Number Analyzed 4 participants
4
 100.0%
CR achieved with intermediate risk cytogenetics Number Analyzed 32 participants
26
  81.3%
CR + CRp achieved with intermediate risk cyto. Number Analyzed 32 participants
27
  84.4%
CR achieved with unfavorable risk cytogenetics Number Analyzed 13 participants
8
  61.5%
CR + CRp achieved with unfavorable risk cyto. Number Analyzed 13 participants
10
  76.9%
2.Primary Outcome
Title Duration of Remission
Hide Description With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: weeks
7
(4 to 84)
3.Primary Outcome
Title Time to Progression
Hide Description With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: weeks
7
(4 to 84)
4.Primary Outcome
Title Event Free Survival
Hide Description Number of patients in remission at a median follow up of 15 months.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
21
  42.0%
5.Primary Outcome
Title Treatment-related Mortality (TRM)
Hide Description Treatment-related mortality (TRM) data was not collected.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-related mortality (TRM) data was not collected.
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Overall Survival
Hide Description With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
24.3
(15 to 60)
Time Frame [Not Specified]
Adverse Event Reporting Description Other [Not including Serious] Adverse Events were not monitored/assessed.
 
Arm/Group Title Treatment (Chemotherapy and Colony Stimulating Factor)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Chemotherapy and Colony Stimulating Factor)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy and Colony Stimulating Factor)
Affected / at Risk (%) # Events
Total   50/50 (100.00%)    
Blood and lymphatic system disorders   
Coagulation   4/50 (8.00%)  4
Cardiac disorders   
Cardiovascular   2/50 (4.00%)  2
Eye disorders   
Ocular   1/50 (2.00%)  1
Gastrointestinal disorders   
Gastrointestinal   10/50 (20.00%)  10
General disorders   
Pain   1/50 (2.00%)  1
Hepatobiliary disorders   
Liver enzymes   20/50 (40.00%)  20
Hepatobiliary   1/50 (2.00%)  1
Infections and infestations   
infection   50/50 (100.00%)  95
Metabolism and nutrition disorders   
Metabolic   10/50 (20.00%)  10
Nervous system disorders   
Neurologic   6/50 (12.00%)  6
Renal and urinary disorders   
Urinary   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary   31/50 (62.00%)  31
Skin and subcutaneous tissue disorders   
Dermatologic   10/50 (20.00%)  10
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy and Colony Stimulating Factor)
Affected / at Risk (%) # Events
Total   0/0    
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
Layout table for Results Point of Contact information
Name/Title: Pamela Becker, MD, PhD
Organization: University of Washington
Phone: 206-288-7273
EMail: pbecker@uw.edu
Layout table for additonal information
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