Autopsy report · NCT03769181

A Study of Isatuximab-based Therapy in Participants With Lymphoma

“Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 11 months before it stopped.
• 58 participants enrolled.
• Results were posted on the registry 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Sanofi

Sponsor type

Industry

Conditions

Lymphoma

Interventions

isatuximab SAR650984; cemiplimab REGN2810

Participants

58

Sites

20

Countries

France, Italy, Netherlands, Portugal, South Korea, Spain, Taiwan

Trials that died the same way

• A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
  “Study was stopped following interim analysis.” (85% match in meaning)
• Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
  “Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts.” (81% match in meaning)
• Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation
  “Study was stopped after interim analysis and slow enrollment.” (81% match in meaning)
• Adherence to Antidepressant Treatment in Subjects With Depression
  “The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.” (79% match in meaning)
• Moxonidine in Patients Undergoing Vascular Surgery
  “Study was stopped after pre-definied interim analysis because of no effects” (79% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.