Three deviations from the investigational plan, including late reporting of nearly a dozen serious adverse events (SAE), put participant safety at risk in a phase 3 trial conducted at Northwestern University’s Robert Lurie Medical Research Center in Chicago, Ill., a recent FDA inspection revealed.

The agency’s May 2-6 inspection of a chronic lymphocytic leukemia trial led by investigator Shuo Ma, an oncologist and professor of medicine at Northwestern University, turned up three serious observations, the first of which involved the treatment regimen. Specifically, a trial participant was dispensed/took one of the trial’s investigational products, Venetoclax, a number of days more than they should have according to the protocol.

In addition, eleven SAEs ranging from chest pain to white blood cell increase were not reported promptly.

The 483 redacts the dates the SAEs occurred, were detected by sites and were submitted, but the agency says the SAEs “were not reported within the required timeframes as specified per the protocol.”

Lastly, a participant was given investigational product that wasn’t held according to protocol. Specifically, the participant’s Venetoclax was temporarily held after they experienced neutropenia but they still received Imbruvia (ibrutinib) despite their condition and the need to wait until their neutrophil counts recovered. During adverse event attribution, neutropenia was noted as “possibly related” to their taking Imbruvia.

The trial has an estimated enrollment of 720 participants and is listed as active/not recruiting on ClinicalTrials.gov.

Read the Form 483 here: https://bit.ly/3LV0pjL.