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Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795132
First Posted: November 21, 2008
Last Update Posted: July 30, 2013
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.
Information provided by (Responsible Party):
University of Utah
Results First Submitted: January 30, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Leukaemia
Chronic Disease
Leukemia
Myelodysplasia
Lymphoma
Interventions: Drug: Busulfan
Drug: Anti-Thymocyte Globulin
Drug: Fludarabine
Drug: Cyclosporine
Drug: Mycophenolate mofetil

  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
No text entered.

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
All Study Participants This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.

Participant Flow:   Overall Study
    All Study Participants
STARTED   47 
COMPLETED   44 
NOT COMPLETED   3 
Death                1 
Relapse                2 



  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
All Study Participants This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 47 
Age 
[Units: Participants]
 
<=18 years   35 
Between 18 and 65 years   12 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 13  (9.899) 
Gender 
[Units: Participants]
 
Female   22 
Male   25 
Region of Enrollment 
[Units: Participants]
 
United States   35 
Canada   8 
Australia   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments   [ Time Frame: 24 months ]

2.  Secondary:   Two Year Overall Survival   [ Time Frame: 24 months ]

3.  Secondary:   Number of Participants Who Experienced Transplantation-related Mortality (TRM)   [ Time Frame: 24 months ]


  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
Participants who experienced early relapse or death before engraftment were excluded from analysis.


  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. Michael Pulsipher
Organization: University of Utah
phone: 801-588-2680
e-mail: michael.pulsipher@hsc.utah.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00795132     History of Changes
Other Study ID Numbers: HCI12073
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: January 30, 2012
Results First Posted: August 20, 2012
Last Update Posted: July 30, 2013