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NCT03687957 · ClinicalTrials.gov registry record · Phase 1
rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
A Phase 1 study of Glioma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT03687957 is a Phase 1 study of Glioma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03687957, a Phase 1 study of Glioma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG). A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard 3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte counts will use placebo-controlled randomization in HGG patients whose treatment include the standard radiation therapy (RT) and temozolomide (TMZ).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Temozolomide
- RADIATION Radiation therapy
- DRUG rhIL-7-hyFc
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2028-04-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03687957
The ClinicalTrials.gov registry entry for NCT03687957 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (80% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03687957 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03687957 about?
NCT03687957 is a clinical study titled "rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide". The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG). A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested us...
What is the current status of trial NCT03687957?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2019-01-04. Estimated completion is 2028-04-13.
What conditions does trial NCT03687957 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT03687957?
The interventions under investigation include: Placebo (DRUG), Temozolomide (DRUG), Radiation therapy (RADIATION), rhIL-7-hyFc (DRUG).
Who is sponsoring clinical trial NCT03687957?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03687957 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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