Trial · NCT00567567

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

NCT00567567, Phase 3, Completed, Children's Oncology Group; results first posted 2017-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma. Trials, record NCT00567567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567567

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Trial

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

Title: Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
NCT number: NCT00567567
Status: Completed
Phases: Phase 3
Enrollment: 665 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
Interventions: Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, Cisplatin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, External Beam Radiation Therapy, Filgrastim, Isotretinoin, Laboratory Biomarker Analysis, Melphalan, Peripheral Blood Stem Cell Transplantation, Pharmacological Study, Thiotepa, Topotecan Hydrochloride, Vincristine Sulfate Liposome
First posted: 2007-12-05
Last updated: 2022-04-28
Results first posted: 2017-06-27

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Event-free Survival Rate	Three years, from time of randomization	Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)
Primary	Response After Induction Therapy	Study enrollment to the end of induction therapy	Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.
Primary	Incidence Rate of Local Recurrence	Up to 3 years	Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.
Secondary	Duration of Greater Than or Equal to Grade 3 Neutropenia	Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days	A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.
Secondary	Duration of Greater Than or Equal to Grade 3 Thrombocytopenia	Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days	A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.
Secondary	Proportion of Patients With a Polymorphism	Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days	A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.
Secondary	Surgical Response	Up to 3 years	Percentage of patients who achieved a surgical complete resection
Secondary	Type of Surgical or Radiotherapy Complication	Up to 3 years	The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.
Secondary	Intraspinal Extension	Up to 5 years	Percentage of patients with primary tumors with intraspinal extension.
Secondary	Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies	Day 1 of each course	Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival Rate	Three years, from time of randomization	All eligible, randomized patients.	percent probability	NUMBER
PRIMARY	Response After Induction Therapy	Study enrollment to the end of induction therapy	Eligible patients evaluated for response at the end of induction therapy.	Proportion participants that responded	NUMBER
PRIMARY	Incidence Rate of Local Recurrence	Up to 3 years	Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.	Percentage 3-year cumulative incidence	NUMBER
SECONDARY	Duration of Greater Than or Equal to Grade 3 Neutropenia	Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days	Eligible patients with available polymorphism and neutropenia toxicity data.	Days	MEDIAN
SECONDARY	Duration of Greater Than or Equal to Grade 3 Thrombocytopenia	Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days	Eligible patients with available polymorphism and thrombocytopenia toxicity data.	Days	MEDIAN
SECONDARY	Proportion of Patients With a Polymorphism	Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days	Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.	Proportion of patients	NUMBER
SECONDARY	Surgical Response	Up to 3 years	All eligible patients enrolled on ANBL0532.	Percentage of patients	NUMBER
SECONDARY	Type of Surgical or Radiotherapy Complication	Up to 3 years	All eligible patients enrolled on ANBL0532.	Percentage of patients	NUMBER
SECONDARY	Intraspinal Extension	Up to 5 years	All eligible patients enrolled on ANBL0532.	Percentage of patients	NUMBER
SECONDARY	Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies	Day 1 of each course	Eligible patients evaluated for peak serum concentration level of isotretinoin.	Micromolar	MEDIAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group38

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

Outcome	Group	Value	Spread	Units
Event-free Survival Rate	Single HST (CEM)	48.8	95% Confidence Interval 41.1 to 56.5	percent probability
Event-free Survival Rate	Tandem HST (CEM), Randomly Assigned	61.8	95% Confidence Interval 53.8 to 69.8	percent probability
Response After Induction Therapy	Single HST (CEM)	0.54	95% Confidence Interval 0.47 to 0.61	Proportion participants that responded
Response After Induction Therapy	Tandem HST (CEM), Randomly Assigned	0.48	95% Confidence Interval 0.41 to 0.56	Proportion participants that responded
Response After Induction Therapy	Not Assigned	0.35	95% Confidence Interval 0.29 to 0.41	Proportion participants that responded
Incidence Rate of Local Recurrence	Single HST (CEM)	15.7	95% Confidence Interval 7.5 to 23.9	Percentage 3-year cumulative incidence
Duration of Greater Than or Equal to Grade 3 Neutropenia	Single HST (CEM)	7	Full Range 0 to 20	Days
Duration of Greater Than or Equal to Grade 3 Neutropenia	Tandem HST (CEM), Randomly Assigned	7	Full Range 0 to 39	Days
Duration of Greater Than or Equal to Grade 3 Neutropenia	Not Assigned	7	Full Range 0 to 35	Days
Duration of Greater Than or Equal to Grade 3 Thrombocytopenia	Single HST (CEM)	4	Full Range 0 to 30	Days

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Single HST (CEM)	210
Overall Study	STARTED	Tandem HST (CEM), Randomly Assigned	176
Overall Study	STARTED	Not Assigned	279
Overall Study	COMPLETED	Single HST (CEM)	58
Overall Study	COMPLETED	Tandem HST (CEM), Randomly Assigned	42
Overall Study	COMPLETED	Not Assigned	1
Overall Study	NOT COMPLETED	Single HST (CEM)	152
Overall Study	NOT COMPLETED	Tandem HST (CEM), Randomly Assigned	134
Overall Study	NOT COMPLETED	Not Assigned	278

Source ClinicalTrials.gov

Adverse events681

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	Events
other	13200-Anemia	Blood and lymphatic system disorders	Single HST (CEM)	23	206	35
other	13200-Anemia	Blood and lymphatic system disorders	Tandem HST (CEM), Randomly Assigned	22	176	37
other	13200-Anemia	Blood and lymphatic system disorders	Not Assigned	33	269	42
other	17200-Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Single HST (CEM)	0	206	0
other	17200-Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Tandem HST (CEM), Randomly Assigned	1	176	1
other	17200-Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Not Assigned	0	269	0
other	25800-Disseminated intravascular coagulation	Blood and lymphatic system disorders	Single HST (CEM)	2	206	2
other	25800-Disseminated intravascular coagulation	Blood and lymphatic system disorders	Tandem HST (CEM), Randomly Assigned	0	176	0
other	25800-Disseminated intravascular coagulation	Blood and lymphatic system disorders	Not Assigned	1	269	1
other	33300-Febrile neutropenia	Blood and lymphatic system disorders	Single HST (CEM)	32	206	46

1 to 10 of 681Source ClinicalTrials.gov

See all 681 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single HST (CEM)
Total, all-cause mortality	Tandem HST (CEM), Randomly Assigned
Total, all-cause mortality	Not Assigned
Total, other adverse events	Single HST (CEM)	196	206
Total, other adverse events	Tandem HST (CEM), Randomly Assigned	163	176
Total, other adverse events	Not Assigned	230	269
Total, serious adverse events	Single HST (CEM)	16	206
Total, serious adverse events	Tandem HST (CEM), Randomly Assigned	15	176
Total, serious adverse events	Not Assigned	12	269

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31454045	DERIVED	PubMed
32530765	DERIVED	PubMed
40036726	DERIVED	PubMed

Grants2

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	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons0

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

None in this release.

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.

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