Cold Agglutinin Disease Real World Evidence Registry

Running, not enrolling

Conditions studied: Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)

In brief

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

Key facts

Study ID

NCT05791708

Run by

RECORDATI GROUP

People needed

429

Starts

2019-12-12

Expected to finish

2028-11-02

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient aged ≥18 years
• Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
• Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

You may not qualify if…

• Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
• Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.

Where it is running

• SLO Oncology and Hematology Site Number : 1235 — San Luis Obispo, California, United States
• Mission Hope Medical Oncology Site Number : 1241 — Santa Maria, California, United States
• MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208 — Washington D.C., District of Columbia, United States
• Piedmont Cancer Institute, P.C Site Number : 1226 — Atlanta, Georgia, United States
• Orchard Heathcare Research Inc. Site Number : 1202 — Skokie, Illinois, United States
• Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220 — Sioux City, Iowa, United States
• Reliant Medical Group Site Number : 1205 — Worcester, Massachusetts, United States
• Henry Ford Hospital Site Number : 1232 — Detroit, Michigan, United States
• Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231 — Lake Success, New York, United States
• Center for Blood Disorders Site Number : 1214 — New York, New York, United States
• SUNY Upstate Medical University Site Number : 1221 — Syracuse, New York, United States
• Investigational Site Number : 3612 — Leeds, United Kingdom
• Brody School of Medicine at East Carolina University Site Number : 1203 — Greenville, North Carolina, United States
• Cleveland Clinic Foundation Site Number : 1207 — Cleveland, Ohio, United States
• The Ohio State University Site Number : 1236 — Columbus, Ohio, United States
• Hematology Oncology Associates, PC Site Number : 1211 — Medford, Oregon, United States
• University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210 — Pittsburgh, Pennsylvania, United States
• UT Medical Center Cancer Institute Site Number : 1237 — Knoxville, Tennessee, United States
• University of Washingtion Seattle Cancer Care Alliance Site Number : 1238 — Seattle, Washington, United States
• Investigational Site Number : 3101 — Salzburg, Austria
• Investigational Site Number : 3102 — Vienna, Austria
• Investigational Site Number : 3222 — Amiens, France
• Investigational Site Number : 3214 — Angers, France
• Investigational Site Number : 3204 — Cesson-Sévigné, France
• University of Alabama at Birmingham Site Number : 1230 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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