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Trial record 91 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT00795132
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : August 20, 2012
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
University of Utah

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
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 47
Completed 44
Not Completed 3
Reason Not Completed
Death             1
Relapse             2
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
35
  74.5%
Between 18 and 65 years
12
  25.5%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
13  (9.899)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
22
  46.8%
Male
25
  53.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
United States 35
Canada 8
Australia 4
1.Primary Outcome
Title Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments
Hide Description Assessed donor engraftment in very high risk pediatric patients.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.
Arm/Group Title Related BM PBSC Unrelated BM PBSC Unrelated Cord Blood
Hide Arm/Group Description:
Related donor: bone marrow or peripheral blood stem cell (PBSC)
Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
Unrelated donor: Cord Blood
Overall Number of Participants Analyzed 16 18 10
Measure Type: Number
Unit of Measure: participants
16 18 10
2.Secondary Outcome
Title Two Year Overall Survival
Hide Description The probability that a given patient will be alive two years after transplantation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants were analyzed.
Arm/Group Title Related BM PBSC Unrelated BM PBSC Unrelated Cord Blood
Hide Arm/Group Description:
All participants were analyzed.
All participants were analyzed.
All participants were analyzed.
Overall Number of Participants Analyzed 16 19 12
Mean (Standard Error)
Unit of Measure: probability
0.501  (0.141) 0.395  (0.120) 0.438  (0.165)
3.Secondary Outcome
Title Number of Participants Who Experienced Transplantation-related Mortality (TRM)
Hide Description Cumulative incidence transplantation-related mortality (TRM)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All incidences of enrolled patients were analyzed.
Arm/Group Title Related BM PBSC Unrelated BM PBSC Unrelated Cord Blood
Hide Arm/Group Description:
All incidences of enrolled patients were analyzed.
All incidences of enrolled patients were analyzed.
All incidences of enrolled patients were analyzed.
Overall Number of Participants Analyzed 16 19 12
Measure Type: Number
Unit of Measure: participants
0 5 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/47 (0.00%) 
Participants who experienced early relapse or death before engraftment were excluded from analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Pulsipher
Organization: University of Utah
Phone: 801-588-2680
EMail: michael.pulsipher@hsc.utah.edu
Layout table for additonal information
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