Phase 2
N=39
Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
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
Bottom Line
View on ClinicalTrials.gov: NCT00309907 ↗Enrolled (actual)
39
Serious AEs
17.9%
Results posted
Feb 2014
Primary outcome: Primary: Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28. — 20; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- etanercept (Biological); methylprednisolone (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28. |
20; 8 | — |
| SECONDARY Survival Rate |
75 | — |
| SECONDARY Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy |
74 | — |
| SECONDARY Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0 |
— | — |
| SECONDARY Plasma Cytokine IL6 Level |
205.2; 28.8; 23.1 | — |
| SECONDARY C-reactive Protein Levels |
28.1; 5.4; 1.8; 4.9; 1; 10.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acute, noninfectious idiopathic pulmonary dysfunction (IPS) as defined by the following:
- Evidence of diffuse lung injury occurring within the first several months after hematopoietic stem cell transplantation for which an infectious etiology is not identified. To meet the criteria for IPS there must be:
- Evidence of widespread alveolar injury
- Diffuse multi-lobar infiltrates on chest x-ray or CT scan
- Evidence for abnormal respiratory physiology based upon 1 of the following:
- Room air oxygen saturation 48 continuous hours prior to study entry
- Must not be receiving > 2 mg/kg/day of methylprednisolone or corticosteroid equivalent within 24 hours of study entry
- Concurrent continuous veno-venous hemofiltration or hemodialysis allowed
Data sourced from ClinicalTrials.gov (NCT00309907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.