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Alkylating agents
Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
Baltimore, MD
Phase 2
Waitlist Available
Led By David M. Loeb, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Approved for 40 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
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.
See full description
Eligible Conditions
- Acute Diarrhea
- Diarrhea
- Gastrointestinal Complications
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Treatment-free Remission at 1 Year After Study Completion
Awards & Highlights
Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: severe autoimmune enteropathyExperimental Treatment2 Interventions
Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Closest Location:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD· 344 miles
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,027 Previous Clinical Trials
41,153,252 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,352 Previous Clinical Trials
14,890,228 Total Patients Enrolled
David M. Loeb, MD, PhDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 Previous Clinical Trials
11 Total Patients Enrolled
Maria Oliva-Hemker, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins