Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00609739
First received: February 6, 2008
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: November 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: cyclosporine
Drug: cytarabine
Drug: filgrastim
Drug: methotrexate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Procedure: allogeneic bone marrow transplantation
Procedure: umbilical cord blood transplantation
Drug: Cis-Retinoic acid

  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
Only 1 patient was enrolled (yr 1999) and later died (yr 2000). Study was terminated due to low accrual.

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
Cytarabine + Mitoxantrone Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.

Participant Flow:   Overall Study
    Cytarabine + Mitoxantrone  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  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
Cytarabine + Mitoxantrone Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.

Baseline Measures
    Cytarabine + Mitoxantrone  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
 
<=18 years     1  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: 1 year ]

2.  Secondary:   Patients With Regimen-Related Toxicity   [ Time Frame: Up to 30 Days Post Study Treatment ]

3.  Secondary:   Patients With Graft-Versus-Host-Disease   [ Time Frame: Up to 30 Days Post Study Treatment ]

4.  Secondary:   Patients Who Relapsed   [ Time Frame: 1 Year ]


  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
Only 1 patient was enrolled (yr 1999) and later died (yr 2000). Study was terminated due to low accrual.


  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: Margaret MacMillan, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-2778
e-mail: macmi002@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00609739     History of Changes
Other Study ID Numbers: 1999LS032, UMN-MT1999-08, 9906M07303
Study First Received: February 6, 2008
Results First Received: November 22, 2011
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration