At a glance
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Effect of rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
In Brief
A Phase 2 clinical trial evaluating rhIL-7-hyFc, Placebo, and 2 other interventions for Glioma. Active but no longer recruiting, targeting 42 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
-Given by intramuscular injection
-Given by intramuscular injection
-Standard of care
-Standard of care