drugset / Trial / NCT01686165

Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL

NCT01686165 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)

Timeline

Start
2012-08-31
Primary completion
2016-02-09
Completion
2017-11-09

Outcome

Missed primary endpoint

paper All patients progressed after receiving therapy; the study did not achieve the required ORR to proceed to the next stage. PMID 28869931 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Belinostat Small molecule — —
Background Rituximab Monoclonal antibody — Intravenous