Cold Agglutinin Disease Clinical Trial

Cold Agglutinin Disease Real World Evidence Registry

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Cold Agglutinin Disease

Estimated Enrollment:

400

Study ID:

NCT05791708

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 68 Locations for this study

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University of Alabama at Birmingham Site Number : 1230
Birmingham Alabama, 35205, United States
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo California, 93401, United States
Mission Hope Medical Oncology Site Number : 1241
Santa Maria California, 93454, United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
Washington District of Columbia, 20007, United States
Piedmont Cancer Institute, P.C Site Number : 1226
Atlanta Georgia, 30290, United States
Orchard Heathcare Research Inc. Site Number : 1202
Skokie Illinois, 60077, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City Iowa, 51101, United States
Reliant Medical Group Site Number : 1205
Worcester Massachusetts, 01608, United States
Henry Ford Hospital Site Number : 1232
Detroit Michigan, 48202, 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, 11042, United States
Center for Blood Disorders Site Number : 1214
New York New York, 10021, United States
SUNY Upstate Medical University Site Number : 1221
Syracuse New York, 13210, United States
Brody School of Medicine at East Carolina University Site Number : 1203
Greenville North Carolina, 27834, United States
Cleveland Clinic Foundation Site Number : 1207
Cleveland Ohio, 44195, United States
The Ohio State University Site Number : 1236
Columbus Ohio, 43210, United States
Hematology Oncology Associates, PC Site Number : 1211
Medford Oregon, 97504, United States
University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
Pittsburgh Pennsylvania, 15232, United States
UT Medical Center Cancer Institute Site Number : 1237
Knoxville Tennessee, 37920, United States
University of Washingtion Seattle Cancer Care Alliance Site Number : 1238
Seattle Washington, 98109, United States
Investigational Site Number : 3101
Salzburg , 5020, Austria
Investigational Site Number : 3102
Wien , 1090, Austria
Investigational Site Number : 3222
Amiens , 80054, France
Investigational Site Number : 3214
Angers , 49933, France
Investigational Site Number : 3204
Cesson Sevigne , 35510, France
Investigational Site Number : 3211
CHALON SUR SAONE Cedex , 71100, France
Investigational Site Number : 3206
Corbeil-Essonnes , 91100, France
Investigational Site Number : 3201
Creteil , 94010, France
Investigational Site Number : 3219
Dijon , 21079, France
Investigational Site Number : 3221
Epagny Metz-Tessy , 74370, France
Investigational Site Number : 3217
Paris , 75013, France
Investigational Site Number : 3213
Pau , 64000, France
Investigational Site Number : 3203
Pessac , 33600, France
Investigational Site Number : 3216
Poitiers , 86021, France
Investigational Site Number : 3202
Quimper , 2900, France
Investigational Site Number : 3220
RENNES Cedex 09 , 35033, France
Investigational Site Number : 3205
Saint Priest En Jarez , 42270, France
Investigational Site Number : 3218
TOULOUSE Cedex 9 , 31059, France
Investigational Site Number : 3301
Essen , 45147, Germany
Investigational Site Number : 3306
Hannover , 30161, Germany
Investigational Site Number : 3302
Landshut , 84036, Germany
Investigational Site Number : 3413
Brescia Lombardia, 25123, Italy
Investigational Site Number : 3410
Campobasso , 86100, Italy
Investigational Site Number : 3403
Novara , 28100, Italy
Investigational Site Number : 3411
Palermo , 90146, Italy
Investigational Site Number : 3415
Pavia , 27100, Italy
Investigational Site Number : 3412
Ravenna , 48121, Italy
Investigational Site Number : 3402
Reggio Calabria , 89133, Italy
Investigational Site Number : 3404
Roma , 00161, Italy
Investigational Site Number : 3405
Terni , 05100, Italy
Investigational Site Number : 2203
Fukushima-shi Fukushima, 960-1, Japan
Investigational Site Number : 2204
Himeji-shi Hyogo, 670-0, Japan
Investigational Site Number : 3701
Barcelona Barcelona [Barcelona], 8036, Spain
Investigational Site Number : 3712
Madrid , 28034, Spain
Investigational Site Number : 3603
Truro Cornwall, TR13L, United Kingdom
Investigational Site Number : 3617
Carlisle Cumbria, CA2 7, United Kingdom
Investigational Site Number : 3608
Gillingham Kent, ME75N, United Kingdom
Investigational Site Number : 3605
London London, City Of, NW1 2, United Kingdom
Investigational Site Number : 3602
Salford Manchester, M6 8H, United Kingdom
Investigational Site Number : 3623
Airdrie North Lanarkshire, ML60J, United Kingdom
Investigational Site Number : 3601
Tyne And Wear North Tyneside, NE29 , United Kingdom
Investigational Site Number : 3613
Middlesbrough North Yorkshire, TS4 3, United Kingdom
Investigational Site Number : 3611
Oxford Oxfordshire, OX3 7, United Kingdom
Investigational Site Number : 3606
Taunton Somerset, TA1 5, United Kingdom
Investigational Site Number : 3618
Birmingham , B15 2, United Kingdom
Investigational Site Number : 3620
Harrow , HA1 3, United Kingdom
Investigational Site Number : 3612
Leeds , LS9 7, United Kingdom
Investigational Site Number : 3607
Liverpool , L7 8X, United Kingdom
Investigational Site Number : 3621
London , E1 2E, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Cold Agglutinin Disease

Estimated Enrollment:

400

Study ID:

NCT05791708

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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