CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
filgrastim +1 morebiological
Likely dose
Cyclophosphamide IV over 1 hour on days 1-4; filgrastim IV or subcutaneously once daily beginning day 10 for 3 days or until blood counts recoverAI-extracted
Key inclusion· 8
  • ✓Diagnosis of severe autoimmune enteropathy resistant to conventional therapy
  • ✓Histologic evidence of severe villous atrophy with intense lymphocytic infiltrate by small intestinal biopsy within past 3 months
  • ✓Disease failed to respond after ≥2 months of corticosteroid therapy (≥0.5 mg/kg/day or ≥40 mg/day for patients >20 kg) AND cyclosporine (≥1 whole blood level >200 ng/mL) or tacrolimus (≥1 whole blood level ≥5 ng/mL)
  • ✓At least 50% of estimated caloric needs provided by parenteral nutrition
Key exclusion· 4
  • ✕Celiac disease (positive antiendomysial antibody or tissue transglutaminase antibody)
  • ✕Primary immunodeficiency or x-linked autoimmunity-allergy dysregulation
  • ✕Known chromosomal abnormality
  • ✕Pregnancy or positive pregnancy test

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00258180
NCT00258180Phase 2Completed
CompareCT.gov

High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy

Johns Hopkins University·interventional·Posted Nov 24, 2005·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating filgrastim and cyclophosphamide for Diarrhea and 2 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy . PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Gastrointestinal Complications, Unspecified Childhood Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2005
Enrollment StartAug 15, 2005
Primary CompletionFeb 24, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.6 years ago

Interventions

filgrastimbiological

Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover

cyclophosphamidedrug

Administered IV over 1 hour on days 1-4