drugset / Trial / NCT02700841

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation

NCT02700841

Phase 2 Terminated 8 enrolled University of Nebraska
RandomizedParallel-groupOpen-labelTreatment

Summary

This pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.

Timeline

Start
2020-01-09
Primary completion
2022-12-21
Completion
2022-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tetanus toxoid vaccine Vaccine Intramuscular
Background Melphalan Small molecule Intravenous

Indications