Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML1107)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00775593
First received: October 17, 2008
Last updated: March 15, 2015
Last verified: March 2015
Results First Received: June 10, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: clofarabine
Drug: temsirolimus

  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
Between April 2009 and June 2010, 60 patients were enrolled in the study at 14 different Italian institutions.

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
Study Group Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.

Participant Flow:   Overall Study
    Study Group  
STARTED     60  
COMPLETED     53  
NOT COMPLETED     7  
Unmet eligibility criteria                 6  
Death                 1  



  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
Study Group Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.

Baseline Measures
    Study Group  
Number of Participants  
[units: participants]
  53  
Age, Customized  
[units: Years]
Mean (Full Range)
  69   (60 to 78)  
Gender  
[units: participants]
 
Female     22  
Male     31  
Region of Enrollment  
[units: participants]
 
Italy     53  



  Outcome Measures
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1.  Primary:   Complete Response Rate   [ Time Frame: At 2 years from study entry ]

2.  Secondary:   Number of Serious Adverse Events Within 2 Years   [ Time Frame: At 2 years from study entry ]

3.  Secondary:   Duration of Response   [ Time Frame: At 2 years from study entry ]

4.  Secondary:   Duration of Survival   [ Time Frame: At 2 years from study entry ]


  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 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.


Results Point of Contact:  
Name/Title: Edoardo La Sala
Organization: GIMEMA
phone: +39 06 70390524
e-mail: e.lasala@gimema.it


No publications provided


Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00775593     History of Changes
Other Study ID Numbers: AML1107, GIMEMA-AML-1107, EUDRACT-2007-005374-31
Study First Received: October 17, 2008
Results First Received: June 10, 2014
Last Updated: March 15, 2015
Health Authority: Italy: Ethics Committee