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NCT06649851 · ClinicalTrials.gov registry record · Phase 2
G-CSF After Chemo-radiation in Patients With Glioblastoma
A Phase 2 study of Glioblastoma (GBM) and MGMT-Methylated Glioblastoma, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06649851: Recruiting Phase 2 study of Glioblastoma (GBM) and MGMT-Methylated Glioblastoma, sponsored by Massachusetts General Hospital.
NCT06649851 is a Phase 2 study of Glioblastoma (GBM) and MGMT-Methylated Glioblastoma that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 78-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06649851, a Phase 2 study of Glioblastoma (GBM) and MGMT-Methylated Glioblastoma, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study involves the study of granulocyte colony stimulating factor (G-CSF) in patients with MGMT-methylated glioblastoma multiforme (GBM) that are undergoing standard chemoradiation. The study aims to evaluate G-CSF's effects on brain health and cognitive function. The name of the study drugs involved in this study are: * G-CSF (also called Filgrastim) * Temozolomide (TMZ), a standard of care chemotherapy drug
Primary Outcome
Adverse events (AEs) will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be listed and tabulated by type and study arm. AEs will also be categorized as study-related or not. The rate of AEs in all participants, both within study arms and overall, will be calculated and reported with exact 95% confidence intervals. All subjects who have completed at least 3 weeks of cranial radiation therapy will be include in the safety analyses.
Conditions Studied
Interventions
- DRUG Granulocyte Colony Stimulating Factor (G-CSF)
- RADIATION Radiation Therapy + Temozolomide
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-04-02 |
| Est. Completion | 2030-01-31 |
| Phase | Phase 2 |
What NCT06649851 shows while recruiting
NCT06649851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 78-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (23% lower).
The record links to 3 conditions, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 2 interventions - of which Granulocyte Colony Stimulating Factor (G-CSF) is the first listed.
NCT06649851 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06649851 about?
NCT06649851 is a clinical study titled "G-CSF After Chemo-radiation in Patients With Glioblastoma". This research study involves the study of granulocyte colony stimulating factor (G-CSF) in patients with MGMT-methylated glioblastoma multiforme (GBM) that are undergoing standard chemoradiation. The study aims to evaluate G-CSF's effects on brain health and cognitive function. The name of the stud...
What is the current status of trial NCT06649851?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-04-02. Estimated completion is 2030-01-31.
What conditions does trial NCT06649851 study?
This clinical trial studies the following conditions: Glioblastoma (GBM), MGMT-Methylated Glioblastoma, Newly Diagnosed Glioblastoma Multiforme.
What interventions are being tested in trial NCT06649851?
The interventions under investigation include: Granulocyte Colony Stimulating Factor (G-CSF) (DRUG), Radiation Therapy + Temozolomide (RADIATION).
Who is sponsoring clinical trial NCT06649851?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649851 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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