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G-CSF After Chemo-radiation in Patients With Glioblastoma

NCT06649851 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this 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

Conditions

  • MGMT-Methylated Glioblastoma
  • Glioblastoma (GBM)
  • Newly Diagnosed Glioblastoma Multiforme

Interventions

DRUG

Granulocyte Colony Stimulating Factor (G-CSF)

Subcutaneously injected study drug; standard target dose of 5-7 µg/kg/d.

RADIATION

Radiation Therapy + Temozolomide

Standard of care chemoradiation is radiation therapy + Temozolomide (TMZ). Chemoradiation (chemo-RT) includes an initial 6-week cycle, followed by a 4-week break, and up to 6 additional cycles of TMZ.

Sponsors & Collaborators

Principal Investigators

  • Jorg Dietrich, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2027-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649851 on ClinicalTrials.gov