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NCT04922723 · ClinicalTrials.gov registry record · Phase 1
Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma
A Phase 1 study of Glioblastoma, sponsored by West Virginia University.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04922723: Active Phase 1 study of Glioblastoma, sponsored by West Virginia University.
NCT04922723 is a Phase 1 study of Glioblastoma that is active but no longer recruiting, run by West Virginia University. The registered enrollment target is 16 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04922723, a Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by West Virginia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially available, is safe and well tolerated when combined with alkylating chemotherapy, radiation therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the frontline treatment regimen of GBM can potentially have a significant clinical benefit. Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2 phases combined.
Primary Outcome
Rate of subjects that experience DLT. Subjects will be evaluated for DLTs after 6 doses of Daratumumab. If there is no DLT in the first 3 patients, the investigators will move forward to conduct the phase II clinical trial. If there is a DLT, another three patients will be enrolled. The study may be suspended with additional discussions in the data monitoring committee if there are ≥2 identified DLTs in the first 3 patients or ≥2 DLTs in the first 6 patients. The sample size justification is bas
Conditions Studied
Interventions
- DRUG Daratumumab
Study Locations (1)
West Virginia
- West Virginia University Cancer Institute Mary Babb Randolph Cancer Center - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
What the registry record for NCT04922723 still lists
NCT04922723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab is the first listed.
NCT04922723 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT04922723 about?
NCT04922723 is a clinical study titled "Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma". TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and ...
What is the current status of trial NCT04922723?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-10-03. Estimated completion is 2026-02.
What conditions does trial NCT04922723 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT04922723?
The interventions under investigation include: Daratumumab (DRUG).
Who is sponsoring clinical trial NCT04922723?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04922723 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04922723's enrollment target sits among peer trials
16 170th of 199 higher than 29 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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