NCT03436862

Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

A Phase II Single Arm Study of Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or progression.

Detailed description

The primary objective of this study is to evaluate safety and tolerability of nivolumab as maintenance therapy early after autologous stem cell transplant in patients with Hodgkin's Lymphoma (HL). Eligible patients will receive nivolumab (240 mg IV) every 2 weeks (± 2 days as long as interval between doses is 12-16 days) starting 45-120 post-transplant for up to a maximum of 6 months of treatment. Response to treatment will be assessed 6 months and 1 year post-transplant using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.

Timeline

• Start date: 2018-05-23
• Primary completion: 2022-05-05
• Completion: 2023-04-04
• First posted: 2018-02-19
• Last updated: 2023-12-05
• Results posted: 2023-06-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study