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NCT00309907 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Juvenile Myelomonocytic Leukemia and Accelerated Phase Chronic Myelogenous Leukemia, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target
20
Study locations

NCT00309907: Completed Phase 2 study of Juvenile Myelomonocytic Leukemia and Accelerated Phase Chronic Myelogenous Leukemia, sponsored by Children's Oncology Group.

NCT00309907 is a Phase 2 study of Juvenile Myelomonocytic Leukemia and Accelerated Phase Chronic Myelogenous Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 39 participants, below the 135-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00309907, a Phase 2 study of Juvenile Myelomonocytic Leukemia and Accelerated Phase Chronic Myelogenous Leukemia, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.

Primary Outcome

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.

Conditions Studied

Juvenile Myelomonocytic Leukemia Accelerated Phase Chronic Myelogenous Leukemia de Novo Myelodysplastic Syndromes Chronic Phase Chronic Myelogenous Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Blastic Phase Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Disseminated Neuroblastoma

Interventions

  • DRUG methylprednisolone
  • BIOLOGICAL etanercept

Study Locations (20)

California

  • Children's Oncology Group - Arcadia
  • Loma Linda University Medical Center - Loma Linda

Indiana

  • Indiana University Cancer Center - Indianapolis
  • Indiana University Medical Center - Indianapolis

New York

  • Columbia University Medical Center - New York
  • New York Medical College - Valhalla

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh

Alabama

  • University of Alabama at Birmingham - Birmingham

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • All Children's Hospital - St. Petersburg

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2006-04
Est. Completion 2011-09
Phase Phase 2
Children's Oncology Group

342 total trials

What the finished NCT00309907 record still lists

NCT00309907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 135-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (71% lower).

The record links to 10 conditions, with Juvenile Myelomonocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which methylprednisolone is the first listed.

NCT00309907 names 20 study sites across 16 states, led by California, Indiana, New York.

Frequently Asked Questions

What is clinical trial NCT00309907 about?

NCT00309907 is a clinical study titled "Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant". This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.

What is the current status of trial NCT00309907?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2006-04. Estimated completion is 2011-09.

What conditions does trial NCT00309907 study?

This clinical trial studies the following conditions: Juvenile Myelomonocytic Leukemia, Accelerated Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission.

What interventions are being tested in trial NCT00309907?

The interventions under investigation include: methylprednisolone (DRUG), etanercept (BIOLOGICAL).

Who is sponsoring clinical trial NCT00309907?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00309907 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Juvenile Myelomonocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00309907's enrollment target sits among peer trials

39 6th of 11 higher than 6 of 11 other Juvenile Myelomonocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Juvenile Myelomonocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00309907, the US trial registry maintained by the National Library of Medicine. NCT00309907 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.