High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00774046
First received: October 15, 2008
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: December 17, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions: Drug: Ara-C
Drug: Mitoxantrone
Drug: Etoposide

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Induction Chemotherapy Followed by Stem Cell Transplant Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant

Participant Flow for 5 periods

Period 1:   Screening
    Induction Chemotherapy Followed by Stem Cell Transplant  
STARTED     116  
COMPLETED     60  
NOT COMPLETED     56  
Not eligible                 56  

Period 2:   Enrollment
    Induction Chemotherapy Followed by Stem Cell Transplant  
STARTED     60  
COMPLETED     32  
NOT COMPLETED     28  
Desired other therapy/refused                 28  

Period 3:   Induction Therapy
    Induction Chemotherapy Followed by Stem Cell Transplant  
STARTED     32  
COMPLETED     32  
NOT COMPLETED     0  

Period 4:   Stem Cell Mobilization
    Induction Chemotherapy Followed by Stem Cell Transplant  
STARTED     10 [1]
COMPLETED     7  
NOT COMPLETED     3  
Count too low (2), sudden death (1)                 3  
[1] For mobilization, the patient must have had a CR and not been a candidate for allogeneic transplant

Period 5:   Autologous Transplant
    Induction Chemotherapy Followed by Stem Cell Transplant  
STARTED     4 [1]
COMPLETED     4  
NOT COMPLETED     0  
[1] 2 patients died in remission and 1 relapsed without having received transplant



  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.
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Reporting Groups
  Description
All Patients Ara-C Mitoxantrone Etoposide

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 23 to 83 )  
Gender  
[units: participants]
 
Female     18  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures
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1.  Primary:   Response to Induction Chemotherapy (CR or PR)   [ Time Frame: Day 28-40 ]

2.  Primary:   Overall Survival   [ Time Frame: Up to 2000 days ]

3.  Primary:   Relapse-free Survival   [ Time Frame: Up to 2000 days ]

4.  Secondary:   Feasibility of Stem Cell Collection   [ Time Frame: 1-5 days from initiation of stem cell collection ]

5.  Secondary:   Numbers of Stem Cells Collected   [ Time Frame: 1-5 days from initiation of stem cell collection ]

6.  Secondary:   Overall Survival in Patients Undergoing Autologous Stem Cell Transplant   [ Time Frame: Up to 817 days ]

7.  Secondary:   Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant   [ Time Frame: Up to 883 days ]


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


Results Point of Contact:  
Name/Title: Dr. Lucy A. Godley
Organization: University of Chicago
phone: 773-702-4140
e-mail: lgodley@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
Study First Received: October 15, 2008
Results First Received: December 17, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board