CARDINAL : A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAplastic Anaemia

Trial Overview Read MoreRead more

This phase III trial is evaluating an investigational drug (Sutimlimab) in patients with Primary Cold Agglutinin disease, who have recently received a blood transfusion.
 

This trial is treating patients with primary cold agglutinin disease.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

Commercial Sponsor

Bioverativ Therapeutics Inc.

Summary

Participants in this trial will receive intravenous sutimlimab in Part A. Participants who complete Part A through to Day 182 (end of treatment) according to the protocol will participate in Part B. Participants in Part B will continue to receive sutimlimab up to one year after last patient out (LPO) in Part A.

Recruiting Hospitals Read MoreRead more

Ballarat Oncology & Haematology
Ballarat
Ms Rosemary Cotton
rosemaryc@ballaratoncology.com.au
03 5339 8000

Not Recruiting Hospitals Read MoreRead more

Closed

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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