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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00774046
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : June 24, 2013
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions: Drug: Ara-C
Drug: Mitoxantrone
Drug: Etoposide

  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
No text entered.

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

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
All Patients Ara-C Mitoxantrone Etoposide

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[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

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

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: Dr. Lucy A. Godley
Organization: University of Chicago
phone: 773-702-4140
e-mail: lgodley@medicine.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
First Submitted: October 15, 2008
First Posted: October 16, 2008
Results First Submitted: December 17, 2012
Results First Posted: June 24, 2013
Last Update Posted: February 11, 2014