Trial · NCT00450450

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

NCT00450450, Phase 3, Completed, Children's Oncology Group; results first posted 2017-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases. Trials, record NCT00450450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450450

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
NCT number: NCT00450450
Status: Completed
Phases: Phase 3
Enrollment: 27 participants, actual
Lead sponsor: Children's Oncology Group
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: allogeneic bone marrow transplantation, laboratory biomarker analysis, filgrastim
First posted: 2007-03-22
Last updated: 2022-04-28
Results first posted: 2017-05-09
Limitations and caveats: ASCT0631 is closed to further patient entry as of 11/25/2011 due to poor accrual.

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Estimated Two-year Event-free Survival (EFS)	at 2 years	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.
Secondary	Estimated Graft Failure Rate	Up to 10 years	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.
Secondary	Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)	Up to 3 months	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.
Secondary	Estimated 100-day Transplant Related Mortality (TRM) Percentage	100 days	Death in a patient after transplant due to protocol treatment is defined as an TRM.
Secondary	Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)	18 months post-transplant	cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
Secondary	Estimated Median Time to Neutrophil Engraftment	Up to 10 years	Median Time from transplant to neutrophil engraftment
Secondary	Estimated Median Length of Initial Hospitalization	Up to 10 years	Estimated and compared between randomization arms using the Wilcoxon rank-sum test.
Other	Immune Reconstitution	Up to 1 year	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.
Other	Infused Nucleated and CD34+ Cell Doses	Up to 10 years	Compared using the Wilcoxon rank-sum test.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Estimated Two-year Event-free Survival (EFS)	at 2 years	Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.	Percentage of patients	NUMBER
SECONDARY	Estimated Graft Failure Rate	Up to 10 years	One patient is inevaluable for EFS on experimental arm and is excluded from analysis.	Percentage of patients	NUMBER
SECONDARY	Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)	Up to 3 months	One patient is inevaluable and is excluded from analysis.	Percentage of patients	NUMBER
SECONDARY	Estimated 100-day Transplant Related Mortality (TRM) Percentage	100 days	One patient is inevaluable and is excluded from analysis.	percentage of patients	NUMBER
SECONDARY	Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)	18 months post-transplant	Included only patients survived beyond 100 days.	percentage of patients	NUMBER
SECONDARY	Estimated Median Time to Neutrophil Engraftment	Up to 10 years	One patient was inevaluable and excluded from the analysis.	Days	MEDIAN
SECONDARY	Estimated Median Length of Initial Hospitalization	Up to 10 years	Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.
OTHER_PRE_SPECIFIED	Immune Reconstitution	Up to 1 year	Data are not collected for this study.
OTHER_PRE_SPECIFIED	Infused Nucleated and CD34+ Cell Doses	Up to 10 years	Data are not collected for this study.

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Estimated Two-year Event-free Survival (EFS)	Control BM Arm	66	95% Confidence Interval 32 to 86	Percentage of patients
Estimated Two-year Event-free Survival (EFS)	Experimental G-BM Arm	83	95% Confidence Interval 47 to 96	Percentage of patients
Estimated Graft Failure Rate	Control BM Arm	0		Percentage of patients
Estimated Graft Failure Rate	Experimental G-BM Arm	0		Percentage of patients
Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)	Control BM Arm	7.69		Percentage of patients
Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)	Experimental G-BM Arm	15.38		Percentage of patients
Estimated 100-day Transplant Related Mortality (TRM) Percentage	Control BM Arm	0		percentage of patients
Estimated 100-day Transplant Related Mortality (TRM) Percentage	Experimental G-BM Arm	7.69		percentage of patients
Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)	Control BM Arm	7.69		percentage of patients
Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)	Experimental G-BM Arm	0		percentage of patients

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Control BM Arm	13
Overall Study	STARTED	Experimental G-BM Arm	14
Overall Study	COMPLETED	Control BM Arm	8
Overall Study	COMPLETED	Experimental G-BM Arm	11
Overall Study	NOT COMPLETED	Control BM Arm	5
Overall Study	NOT COMPLETED	Experimental G-BM Arm	3

Source ClinicalTrials.gov

Adverse events68

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Control BM Arm	0	13
other	Abdominal pain	Gastrointestinal disorders	Experimental G-BM Arm	1	13
other	Anemia	Blood and lymphatic system disorders	Control BM Arm	4	13
other	Anemia	Blood and lymphatic system disorders	Experimental G-BM Arm	0	13
other	Anorexia	Metabolism and nutrition disorders	Control BM Arm	0	13
other	Anorexia	Metabolism and nutrition disorders	Experimental G-BM Arm	2	13
other	Autoimmune disorder	Immune system disorders	Control BM Arm	0	13
other	Autoimmune disorder	Immune system disorders	Experimental G-BM Arm	1	13
other	Bladder infection	Infections and infestations	Control BM Arm	1	13
other	Bladder infection	Infections and infestations	Experimental G-BM Arm	0	13

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control BM Arm
Total, all-cause mortality	Experimental G-BM Arm
Total, other adverse events	Control BM Arm	8	13
Total, other adverse events	Experimental G-BM Arm	7	13
Total, serious adverse events	Control BM Arm	1	13
Total, serious adverse events	Experimental G-BM Arm	0	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Experimental G-BM Arm vs Control BM Arm: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00450450

GET https://conductscience.org/api/trials/v1/NCT00450450/events?page=2

API reference For AI assistants