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Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00703820
Recruitment Status : Active, not recruiting
First Posted : June 24, 2008
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Myeloid Leukemia
Interventions: Drug: Cytarabine
Drug: Daunorubicin
Drug: Etoposide
Drug: Clofarabine
Device: CliniMACS

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
324 participants enrolled between August 2008 and March 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.

Reporting Groups
  Description
Cytarabine+Daunorubicin+Etoposide Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Clofarabine+Cytarabine Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.

Participant Flow:   Overall Study
    Cytarabine+Daunorubicin+Etoposide   Clofarabine+Cytarabine
STARTED   133   129 
COMPLETED   98   95 
NOT COMPLETED   35   34 
Adverse Event                12                17 
Death                5                0 
Lack of Efficacy                11                11 
Received non-protocol therapy                1                0 
Physician Decision                4                5 
Withdrawal by Subject                2                1 



  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
Cytarabine+Daunorubicin+Etoposide Participants receive Cytarabine + Daunorubicin + Etoposide as a first course followed by risk-adapted therapy.
Clofarabine+Cytarabine Participants receive Clofarabine + Cytarabine as a first course followed by risk-adapted therapy.
Total Total of all reporting groups

Baseline Measures
   Cytarabine+Daunorubicin+Etoposide   Clofarabine+Cytarabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   129   262 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.57  (6.00)   9.05  (6.40)   9.31  (6.18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   60   59   119 
Male   73   70   143 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      28  21.1%      17  13.2%      45  17.2% 
Not Hispanic or Latino      99  74.4%      110  85.3%      209  79.8% 
Unknown or Not Reported      6   4.5%      2   1.6%      8   3.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      6   4.5%      12   9.3%      18   6.9% 
Native Hawaiian or Other Pacific Islander      1   0.8%      1   0.8%      2   0.8% 
Black or African American      20  15.0%      21  16.3%      41  15.6% 
White      100  75.2%      81  62.8%      181  69.1% 
More than one race      4   3.0%      5   3.9%      9   3.4% 
Unknown or Not Reported      2   1.5%      9   7.0%      11   4.2% 


  Outcome Measures

1.  Primary:   Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry   [ Time Frame: Day 22 MRD measurement after one course of therapy ]

2.  Secondary:   Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.   [ Time Frame: 3 years after completion of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.   [ Time Frame: 3 years after completion of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Results Point of Contact:  
Name/Title: Jeffrey E. Rubnitz, MD, PhD
Organization: St. Jude Children's Research Hospital
phone: 901-595-2388
e-mail: jeffrey.rubnitz@stjude.org



Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00703820     History of Changes
Other Study ID Numbers: AML08
R01CA138744 ( U.S. NIH Grant/Contract )
R01CA115422 ( U.S. NIH Grant/Contract )
R01CA132946 ( U.S. NIH Grant/Contract )
NCI-2011-03659 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: March 2, 2018
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018