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NCT03927222 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
A Phase 2 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03927222 is a Phase 2 study that was terminated before completion, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP. The registered enrollment target is 6 participants.
The verdict
NCT03927222, a Phase 2 study, was terminated before completion, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor resection, are cytomegalovirus (CMV) positive and unmethylated, and completed standard temozolomide (TMZ) and radiation treatment. After completion of the standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day 23.
Interventions
- DRUG Temozolomide
- BIOLOGICAL GM-CSF
- BIOLOGICAL Tetanus-Diphtheria Toxoid (Td)
- BIOLOGICAL Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF
- BIOLOGICAL 111-Indium-labeling of Cells for in vivo Trafficking Studies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03927222
The ClinicalTrials.gov registry entry for NCT03927222 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT03927222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03927222 about?
NCT03927222 is a clinical study titled "Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma". This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor rese...
What is the current status of trial NCT03927222?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-09-30. Estimated completion is 2023-02-10.
What interventions are being tested in trial NCT03927222?
The interventions under investigation include: Temozolomide (DRUG), GM-CSF (BIOLOGICAL), Tetanus-Diphtheria Toxoid (Td) (BIOLOGICAL), Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF (BIOLOGICAL), 111-Indium-labeling of Cells for in vivo Trafficking Studies (BIOLOGICAL).
Who is sponsoring clinical trial NCT03927222?
This trial is sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total clinical trials registered on ClinicalTrials.gov.
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