NCT02151903

Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL

An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Alopexx Oncology, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	DI-Leu16-IL2	DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.

Timeline

• Start date: 2014-11-04
• Primary completion: 2016-07-11
• Completion: 2016-07-11
• First posted: 2014-06-02
• Last updated: 2020-11-27
• Results posted: 2020-11-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study