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Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases

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ClinicalTrials.gov Identifier: NCT00450450
Recruitment Status : Terminated (Poor accrual)
First Posted : March 22, 2007
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Myelodysplastic Syndromes
Chronic Phase Chronic Myelogenous Leukemia
de Novo Myelodysplastic Syndromes
Juvenile Myelomonocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Recurrent Childhood Acute Lymphoblastic Leukemia
Secondary Myelodysplastic Syndromes
Interventions Procedure: allogeneic bone marrow transplantation
Other: laboratory biomarker analysis
Biological: filgrastim
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description Conventional bone marrow transplant (BM) G-CSF (filgrastim) stimulated bone marrow (G-BM)
Period Title: Overall Study
Started 13 14
Completed 8 11
Not Completed 5 3
Reason Not Completed
Death             1             3
Relapse             2             0
Missing Data             2             0
Arm/Group Title Control BM Arm Experimental G-BM Arm Total
Hide Arm/Group Description Conventional bone marrow transplant (BM) G-CSF (filgrastim) stimulated bone marrow (G-BM) Total of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn’t contribute any data. Group 2 AE total is 13.
Age, Continuous  
Median (Full Range)
Unit of measure:  Whole year
Number Analyzed 13 participants 14 participants 27 participants
12
(0 to 20)
11
(3 to 20)
12
(0 to 20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
5
  38.5%
9
  64.3%
14
  51.9%
Male
8
  61.5%
5
  35.7%
13
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Hispanic or Latino
2
  15.4%
3
  21.4%
5
  18.5%
Not Hispanic or Latino
11
  84.6%
11
  78.6%
22
  81.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
  14.3%
2
   7.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
2
  14.3%
3
  11.1%
White
10
  76.9%
9
  64.3%
19
  70.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  15.4%
1
   7.1%
3
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
United States 12 14 26
Australia 1 0 1
1.Primary Outcome
Title Estimated Two-year Event-free Survival (EFS)
Hide Description EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
Time Frame at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
66
(32 to 86)
83
(47 to 96)
2.Secondary Outcome
Title Estimated Graft Failure Rate
Hide Description Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient is inevaluable for EFS on experimental arm and is excluded from analysis.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: Percentage of patients
0 0
3.Secondary Outcome
Title Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)
Hide Description Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient is inevaluable and is excluded from analysis.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: Percentage of patients
7.69 15.38
4.Secondary Outcome
Title Estimated 100-day Transplant Related Mortality (TRM) Percentage
Hide Description Death in a patient after transplant due to protocol treatment is defined as an TRM.
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient is inevaluable and is excluded from analysis.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: percentage of patients
0 7.69
5.Secondary Outcome
Title Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)
Hide Description cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
Time Frame 18 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Included only patients survived beyond 100 days.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of patients
7.69 0
6.Secondary Outcome
Title Estimated Median Time to Neutrophil Engraftment
Hide Description Median Time from transplant to neutrophil engraftment
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was inevaluable and excluded from the analysis.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 13 13
Median (95% Confidence Interval)
Unit of Measure: Days
23
(20 to 25)
20
(16 to 23)
7.Secondary Outcome
Title Estimated Median Length of Initial Hospitalization
Hide Description Estimated and compared between randomization arms using the Wilcoxon rank-sum test.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Immune Reconstitution
Hide Description Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not collected for this study.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Infused Nucleated and CD34+ Cell Doses
Hide Description Compared using the Wilcoxon rank-sum test.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not collected for this study.
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description:
Conventional bone marrow transplant (BM)
G-CSF (filgrastim) stimulated bone marrow (G-BM)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn’t contribute any data. Group 2 AE total is 13.
 
Arm/Group Title Control BM Arm Experimental G-BM Arm
Hide Arm/Group Description Conventional bone marrow transplant (BM) G-CSF (filgrastim) stimulated bone marrow (G-BM)
All-Cause Mortality
Control BM Arm Experimental G-BM Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control BM Arm Experimental G-BM Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   1/13 (7.69%)   0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1/13 (7.69%)  0/13 (0.00%) 
Pneumonitis  1/13 (7.69%)  0/13 (0.00%) 
Pneumothorax  1/13 (7.69%)  0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control BM Arm Experimental G-BM Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   8/13 (61.54%)   7/13 (53.85%) 
Blood and lymphatic system disorders     
Anemia  4/13 (30.77%)  0/13 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  0/13 (0.00%)  1/13 (7.69%) 
Mucositis oral  2/13 (15.38%)  3/13 (23.08%) 
Nausea  1/13 (7.69%)  0/13 (0.00%) 
Oral pain  1/13 (7.69%)  1/13 (7.69%) 
Rectal mucositis  0/13 (0.00%)  1/13 (7.69%) 
General disorders     
Death NOS  0/13 (0.00%)  1/13 (7.69%) 
Edema face  0/13 (0.00%)  1/13 (7.69%) 
Multi-organ failure  0/13 (0.00%)  1/13 (7.69%) 
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify  0/13 (0.00%)  1/13 (7.69%) 
Immune system disorders     
Autoimmune disorder  0/13 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Bladder infection  1/13 (7.69%)  0/13 (0.00%) 
Infections and infestations - Other, specify  5/13 (38.46%)  0/13 (0.00%) 
Lung infection  1/13 (7.69%)  0/13 (0.00%) 
Peripheral nerve infection  1/13 (7.69%)  0/13 (0.00%) 
Pharyngitis  1/13 (7.69%)  0/13 (0.00%) 
Skin infection  0/13 (0.00%)  1/13 (7.69%) 
Investigations     
Blood bilirubin increased  1/13 (7.69%)  1/13 (7.69%) 
Lymphocyte count decreased  2/13 (15.38%)  1/13 (7.69%) 
Neutrophil count decreased  5/13 (38.46%)  3/13 (23.08%) 
Platelet count decreased  5/13 (38.46%)  5/13 (38.46%) 
White blood cell decreased  5/13 (38.46%)  2/13 (15.38%) 
Metabolism and nutrition disorders     
Anorexia  0/13 (0.00%)  2/13 (15.38%) 
Hyperglycemia  1/13 (7.69%)  1/13 (7.69%) 
Hypokalemia  1/13 (7.69%)  2/13 (15.38%) 
Hyponatremia  1/13 (7.69%)  0/13 (0.00%) 
Renal and urinary disorders     
Hematuria  2/13 (15.38%)  0/13 (0.00%) 
Renal and urinary disorders - Other, specify  1/13 (7.69%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  0/13 (0.00%)  1/13 (7.69%) 
Hypoxia  0/13 (0.00%)  1/13 (7.69%) 
Pharyngolaryngeal pain  0/13 (0.00%)  1/13 (7.69%) 
ASCT0631 is closed to further patient entry as of 11/25/2011 due to poor accrual.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00450450     History of Changes
Other Study ID Numbers: ASCT0631
NCI-2009-01069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ASCT0631 ( Other Identifier: Children's Oncology Group )
COG-PBMTC-STC051 ( Other Identifier: Children's Oncology Group )
CDR0000532926 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: November 10, 2016
Results First Posted: May 9, 2017
Last Update Posted: May 9, 2017