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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: Active Phase 1 study of Glioma, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
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 |
What the registry record for NCT03687957 still lists
NCT03687957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT03687957's enrollment target sits among peer trials
42 44th of 87 higher than 42 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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.
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