Request a Proposal  

Indolent NHL Immuno-Oncology Rescue Study

A Rare Disease Case Study

Download Case Study

Background

Non-Hodgkin's Lymphoma

(Indolent NHL, PI3K inhibitor)

Pharm-Olam was contracted to provide rescue study services by a small-emerging biotech company after the originally contracted CRO had difficultly enrolling patients in the challenging indication of refractory, indolent NHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma), as well as other quality issues.

Pharm-Olam set up additional sites in Western and Eastern Europe which kept enrolment on target. The sponsor later decided to hand over sites managed by the other CRO in Canada, UK, and the US.

Study Overview

  • Phase: II
  • Design: open label, single group
  • Study Population: 128 subjects
  • Services: regulatory (VHP submission), monitoring, project management, medical monitoring, data management
Country Sites Radomized Patients Patients/site/month
Belarus 4 10 0.22
Belgium 3 2 0.05
Bulgaria 4 5 0.11
Canada 3 9 0.11
Czecch Rep. 3 9 0.23
France 6 6 0.07
Georgia 2 1 0.04
Hungary 3 7 0.17
Italy 12 21 0.12
Spain 5 11 0.03
UK 8 11 0.10
US  35 45 0.05

 

Study Challenges & Solutions

Download PDF Version