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Trial record 80 of 144 for:    "Acute promyelocytic leukemia"

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00602225
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : September 8, 2017
Last Update Posted : March 9, 2018
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 Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
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)
Adult Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Interventions Drug: clofarabine
Drug: cytarabine
Biological: filgrastim
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Baseline Participants 50
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[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants
53
(19 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
14
  28.0%
Male
36
  72.0%
AML Onset: de novo   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
32
  64.0%
[1]
Measure Description: Number of participants whose diagnosis of Acute Myeloid Leukemia was not preceded by an Antecedent Hematological Disorder or treatment with chemotherapy/radiation.
AML Onset: secondary   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
18
  36.0%
[1]
Measure Description: Number of participants whose diagnosis of Acute Myeloid Leukemia was preceded by an Antecedent Hematological Disorder or treatment with chemotherapy/radiation.
Relapsed   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
32
  64.0%
[1]
Measure Description: Number of patients with relapsed Acute Myeloid Leukemia
First salvage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
32
  64.0%
[1]
Measure Description: Number of participants for whom treatment on this protocol was considered first salvage therapy.
Second or greater salvage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
18
  36.0%
[1]
Measure Description: Number of participants for whom treatment on this protocol was considered second or greater salvage therapy.
Refractory   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
18
  36.0%
[1]
Measure Description: Number of participants whose disease was considered refractory at the time of enrollment.
Favorable cytogenetics (at initial diagnosis)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
3
   6.0%
[1]
Measure Description: Number of participants who had favorable risk cytogenetics at initial diagnosis.
Intermediate cytogenetics (at initial diagnosis)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
27
  54.0%
[1]
Measure Description: Number of participants who had intermediate risk cytogenetics at initial diagnosis.
Unfavorable cytogenetics (at initial diagnosis)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
20
  40.0%
[1]
Measure Description: Number of participants who had unfavorable risk cytogenetics at initial diagnosis.
Median first CR duration   [1] 
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 32 participants
26
(0 to 100)
[1]
Measure Analysis Population Description: This baseline measure only applies to those participants whose disease was in relapse at the time of enrollment.
1.Primary Outcome
Title Maximum Tolerated Dose of Clofarabine
Hide Description [Not Specified]
Time Frame 45 days after the last dose of clofarabine
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[Not Specified]
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: mg/m^2 of clofarabine
25
2.Primary Outcome
Title Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0
Hide Description [Not Specified]
Time Frame 45 days after the last dose of clofarabine
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[Not Specified]
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.0%
3.Primary Outcome
Title Response Rates by Cytogenetic Risk Category
Hide Description Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.
Time Frame 45 days after the last dose of clofarabine
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Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Favorable risk Complete Remission Number Analyzed 3 participants
3
 100.0%
Intermediate risk Complete remission Number Analyzed 25 participants
10
  40.0%
Unfavorable risk Complete remission Number Analyzed 18 participants
9
  50.0%
4.Primary Outcome
Title Response Rates by Cytogenetic Risk Category and Clofarabine Dose
Hide Description Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).
Time Frame 45 days after the last dose of clofarabine
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Favorable Risk + 25 mg/m^2 achieve CR Number Analyzed 3 participants
2
  66.7%
Intermediate Risk + 15 mg/m^2 achieve CR Number Analyzed 4 participants
2
  50.0%
Intermediate Risk + 20 mg/m^2 achieve CR Number Analyzed 4 participants
3
  75.0%
Intermediate Risk + 25 mg/m^2 achieve CR Number Analyzed 17 participants
5
  29.4%
Intermediate Risk + 25 mg/m^2 achieve CRp Number Analyzed 17 participants
4
  23.5%
Unfavorable Risk + 15 mg/m^2 achieve CR Number Analyzed 4 participants
2
  50.0%
Unfavorable Risk + 20 mg/m^2 achieve CR Number Analyzed 2 participants
1
  50.0%
Unfavorable Risk + 25 mg/m^2 achieve CR Number Analyzed 12 participants
6
  50.0%
Unfavorable Risk + 25 mg/mg^2 achieve CRp Number Analyzed 12 participants
3
  25.0%
5.Primary Outcome
Title Response Rates by Duration First Complete Remission (CR1)
Hide Description Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.
Time Frame 45 days after the last dose of clofarabine
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Duration CR1 (months): 0
12
  57.1%
Duration CR1 (months): 1-6
4
  19.0%
Duration CR1 (months): 6-12
2
   9.5%
Duration CR1 (months): greater than 12
3
  14.3%
6.Primary Outcome
Title Response Rates by Salvage Number
Hide Description Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).
Time Frame 45 days after the last dose of clofarabine
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Salvage number 1 Number Analyzed 33 participants
16
  48.5%
Salvage number 2 Number Analyzed 8 participants
5
  62.5%
Salvage number 3 or greater Number Analyzed 5 participants
0
   0.0%
7.Secondary Outcome
Title Hematologic and Non-hematologic Side Effect Profile
Hide Description [Not Specified]
Time Frame 45 days after the last dose of clofarabine
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Data not collected
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Efficacy
Hide Description Number of Patients Surviving at Five Years
Time Frame At five years after the last dose of clofarabine
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
12
  24.0%
9.Secondary Outcome
Title Disease-free Survival
Hide Description Number of participants who survived and were disease-free at 5 years
Time Frame At five years after the last dose of clofarabine
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.0%
10.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame At five years after the last dose of clofarabine
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
9
(5.2 to 13)
Time Frame [Not Specified]
Adverse Event Reporting Description Other [Non-serious] adverse events were not collected/assessed.
 
Arm/Group Title Arm I
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clofarabine: Given IV

cytarabine: Given IV

filgrastim: Given subcutaneously

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   23/50 (46.00%)    
Gastrointestinal disorders   
Gastrointestinal   6/50 (12.00%)  6
General disorders   
Pain   1/50 (2.00%)  1
Hepatobiliary disorders   
Hepatic transaminases   8/50 (16.00%)  8
Infections and infestations   
infection   20/50 (40.00%)  20
Investigations   
Hyperbilirubinaemia   4/50 (8.00%)  4
Tumor Lysis   1/50 (2.00%)  1
Nervous system disorders   
Neuropathy   1/50 (2.00%)  1
Renal and urinary disorders   
Renal   2/50 (4.00%)  2
Respiratory, thoracic and mediastinal disorders   
Pulmonary   23/50 (46.00%)  23
Skin and subcutaneous tissue disorders   
Skin   5/50 (10.00%)  5
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%
Arm I
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
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Responsible Party: Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier: NCT00602225     History of Changes
Other Study ID Numbers: 6562
NCI-2009-01464 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: January 23, 2008
First Posted: January 28, 2008
Results First Submitted: March 4, 2017
Results First Posted: September 8, 2017
Last Update Posted: March 9, 2018