Trial · NCT00309907

Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant

NCT00309907, Phase 2, Completed, Children's Oncology Group; results first posted 2014-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant. Trials, record NCT00309907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00309907

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Trial

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

Title: Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
NCT number: NCT00309907
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, 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, Disseminated Neuroblastoma, Juvenile Myelomonocytic Leukemia, Previously Treated Childhood Rhabdomyosarcoma, Previously Treated Myelodysplastic Syndromes, Pulmonary Complications, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Neuroblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes
Interventions: etanercept, methylprednisolone
First posted: 2006-04-03
Last updated: 2017-09-29
Results first posted: 2014-02-14

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.	At day 28	Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for \> 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.
Secondary	Survival Rate	Up to day 56	Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.
Secondary	Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy	up to day 56	Pulmonary response is defined as alive \& come off of oxygen .
Secondary	Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0	Up to 56 days	Grade 3-5 organ toxicities attributable to etanercept.
Secondary	Plasma Cytokine IL6 Level	From baseline to days 7 and 28	Estimated mean and standard error of IL6 level
Secondary	C-reactive Protein Levels	From baseline to days 7, 14, 21, and 28	Estimated mean and standard deviation

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.	At day 28	Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.	participants	NUMBER
SECONDARY	Survival Rate	Up to day 56	Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.	percentage of participants	NUMBER
SECONDARY	Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy	up to day 56	Total of 28 patients are evaluable for this outcome.	percentage of participants	NUMBER
SECONDARY	Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0	Up to 56 days	28 patients evaluable for this outcome.	Patients	NUMBER
SECONDARY	Plasma Cytokine IL6 Level	From baseline to days 7 and 28	Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.	pg/ml	MEAN
SECONDARY	C-reactive Protein Levels	From baseline to days 7, 14, 21, and 28	The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group17

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

Outcome	Group	Category	Value	Spread	Units
Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.	Etanercept and Corticosteroid Therapy	With Response	20		participants
Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.	Etanercept and Corticosteroid Therapy	Without Response	8		participants
Survival Rate	Etanercept and Corticosteroid Therapy		75	95% Confidence Interval 55 to 87	percentage of participants
Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy	Etanercept and Corticosteroid Therapy		74		percentage of participants
Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0	Etanercept and Corticosteroid Therapy		0		Patients
Plasma Cytokine IL6 Level	Etanercept and Corticosteroid Therapy	Baseline	205.2	Standard Error 58	pg/ml
Plasma Cytokine IL6 Level	Etanercept and Corticosteroid Therapy	Day 7	28.8	Standard Error 4.4	pg/ml
Plasma Cytokine IL6 Level	Etanercept and Corticosteroid Therapy	Day 28	23.1	Standard Error 3.5	pg/ml
C-reactive Protein Levels	Etanercept and Corticosteroid Therapy	Baseline	28.1	Standard Deviation 59.1	mg/dL
C-reactive Protein Levels	Etanercept and Corticosteroid Therapy	Day 7 Non Responders	5.4	Standard Deviation 11.4	mg/dL

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Etanercept and Corticosteroid Therapy	39
Overall Study	COMPLETED	Etanercept and Corticosteroid Therapy	19
Overall Study	NOT COMPLETED	Etanercept and Corticosteroid Therapy	20

Source ClinicalTrials.gov

Adverse events30

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	Acute kidney injury	Renal and urinary disorders	Etanercept and Corticosteroid Therapy	1	28
other	Ascites	Gastrointestinal disorders	Etanercept and Corticosteroid Therapy	1	28
other	Creatinine increased	Investigations	Etanercept and Corticosteroid Therapy	1	28
other	Enterocolitis infectious	Infections and infestations	Etanercept and Corticosteroid Therapy	1	28
other	Hepatic failure	Hepatobiliary disorders	Etanercept and Corticosteroid Therapy	1	28
other	Hyperglycemia	Metabolism and nutrition disorders	Etanercept and Corticosteroid Therapy	1	28
other	Hypokalemia	Metabolism and nutrition disorders	Etanercept and Corticosteroid Therapy	1	28
other	Infections and infestations - Other, specify	Infections and infestations	Etanercept and Corticosteroid Therapy	1	28
other	Neutrophil count decreased	Investigations	Etanercept and Corticosteroid Therapy	1	28
other	Platelet count decreased	Investigations	Etanercept and Corticosteroid Therapy	1	28

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Etanercept and Corticosteroid Therapy
Total, other adverse events	Etanercept and Corticosteroid Therapy	6	28
Total, serious adverse events	Etanercept and Corticosteroid Therapy	5	28

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 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.

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/NCT00309907

GET https://conductscience.org/api/trials/v1/NCT00309907/events?page=2

API reference For AI assistants