NCT03687957

rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide

Effect of rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	rhIL-7-hyFc	-Given by intramuscular injection
DRUG	Placebo	-Given by intramuscular injection
DRUG	Temozolomide	-Standard of care
RADIATION	Radiation therapy	-Standard of care

Timeline

• Start date: 2019-01-04
• Primary completion: 2023-02-13
• Completion: 2028-04-13
• First posted: 2018-09-27
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study