drugset / Trial / NCT02681302

Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence

NCT02681302 ↗

Phase 1/2 Terminated 46 enrolled Hackensack Meridian Health
NaSingle-groupOpen-labelTreatment

Summary

The goal of this study is to determine the safety and clinical effect of combined checkpoint inhibition administered after autologous hematopoietic stem cell transplantation in each of six clinical cohorts of high risk and recurrent disease. In addition to assessing the incidence and severity of adverse events and rates of complete response and progression free survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire throughout treatment and at the time of disease progression. Investigators will also analyze the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time of relapse.

Timeline

Start
2016-06-07
Primary completion
2024-05-10
Completion
2024-05-10

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of Accrual”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg —
Subject Nivolumab Monoclonal antibody 3 mg/kg —

Indications