A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00373529
First received: September 7, 2006
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: February 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Intervention: Drug: clofarabine

  Participant Flow
  Hide Participant Flow

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
129 patients were screened and 116 participants enrolled/treated at 20 sites.

Reporting Groups
  Description
Clofarabine Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.

Participant Flow:   Overall Study
    Clofarabine  
STARTED     116  
Full Analysis Set     112 [1]
COMPLETED     8 [2]
NOT COMPLETED     108  
Physician Decision                 19  
Withdrawal by Subject                 7  
Adverse Event                 7  
Treatment failure                 36  
Disease recurrence                 10  
Death                 16  
Need for treatment prohibited by study                 1  
Not specified                 8  
Failed independent confirmation of AML                 3  
Consent violation                 1  
[1] 3 Failed Independent Confirmation of AML; 1 consent violation
[2] Completed: initiated full 6 cycles of treatment. Not Completed: initiated <6 cycles of treatment



  Baseline Characteristics
  Hide Baseline Characteristics

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
Clofarabine Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.

Baseline Measures
    Clofarabine  
Number of Participants  
[units: participants]
  112  
Age  
[units: years]
Mean ± Standard Deviation
  71.4  ± 5.92  
Age  
[units: years]
Median ( Full Range )
  71.0  
  ( 60 to 88 )  
Gender  
[units: participants]
 
Female     60  
Male     52  
Race  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     7  
White     98  
Other     2  
Ethnicity  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     108  
Height  
[units: cm]
Mean ± Standard Deviation
  166.50  ± 10.366  
Weight  
[units: kg]
Mean ± Standard Deviation
  78.45  ± 18.191  
Age at Enrollment [1]
[units: participants]
 
>= 70 years     69  
< 70 years     43  
Antecedent Hematologic Disorder [2]
[units: participants]
 
Yes     41  
No     67  
Not reported     4  
Eastern Cooperative Oncology Group Performance Status [3]
[units: participants]
 
ECOG 5     0  
ECOG 4     0  
ECOG 3     0  
ECOG 2     25  
ECOG 1     66  
ECOG 0     21  
Karyotype [4]
[units: participants]
 
Intermediate     46  
Unfavorable     62  
Favorable     0  
Not reported     4  
Participants Summarized by Number of Adverse Prognostic Factors [5]
[units: participants]
 
0 Adverse Prognostic Factors     0  
1 Adverse Prognostic Factor     25  
2 Adverse Prognostic Factors     45  
3 Adverse Prognostic Factors     40  
4 Adverse Prognostic Factors     2  
Participants Summarized by Number of Adverse Prognostic Factors Excluding Intermediate Karyotype [6]
[units: participants]
 
0 Adverse Prognostic Factors     7  
1 Adverse Prognostic Factor     42  
2 Adverse Prognostic Factors     35  
3 Adverse Prognostic Factors     27  
4 Adverse Prognostic Factors     1  
Secondary acute myeloid leukemia (AML) at baseline [7]
[units: participants]
 
Yes     11  
No     101  
[1] Being 70 years old or older is considered an adverse prognostic factor.
[2] The most common risk factor for acute myelogenous leukemia (AML) is the presence of an antecedent hematologic disorder.
[3] Another prognostic factor. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is a scale ranging from 0-5, with 0=fully active, 1=capable of light work, 2=no work but all self-care, 3=limited self-care, 4=completely disabled, 5=dead.
[4] A favorable cytogenetic karyotype is associated with a positive prognostic outcome; an unfavorable cytogenetic karyotype is associated with a negative prognostic outcome. An intermediate karyotype is typically associated with a better outcome than a favorable karyotype, but also associated with a worse outcome compared to a favorable karyotype.
[5] Participant counts by the number of adverse prognostic factors, which include age >= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = intermediate or unfavorable.
[6] Participant counts by the number of adverse prognostic factors, which include age >= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = unfavorable.
[7] The diagnosis of secondary AML is based upon investigator judgment regarding prior ionizing radiation and/or chemotherapy.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)   [ Time Frame: approximately Month 2 ]

2.  Secondary:   Kaplan Meier Estimate for Duration of Remission (DOR)   [ Time Frame: Up to 2 years ]

3.  Secondary:   Kaplan Meier Estimate for Disease-free Survival (DFS)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Kaplan Meier Estimates for Overall Survival (OS)   [ Time Frame: Up to 2 years ]

5.  Secondary:   Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods   [ Time Frame: Up to 2 years ]

6.  Secondary:   Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)   [ Time Frame: up to Day 30 ]

7.  Other Pre-specified:   Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors   [ Time Frame: approximately Month 2 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
phone: 800-745-4447


Publications of Results:

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00373529     History of Changes
Other Study ID Numbers: CLO24300606
Study First Received: September 7, 2006
Results First Received: February 24, 2011
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration