Myelodysplastic Syndromes Clinical Trial
Official title:
Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
The purpose of the Connect® Myeloid disease registry is to provide unique insights into treatment decisions and treatment patterns as they relate to clinical outcomes of patients with myeloid diseases in routine clinical practice. This disease registry will also evaluate molecular and cellular markers that may provide further prognostic classification which may or may not be predictive of therapy and clinical outcomes.
Status | Recruiting |
Enrollment | 2300 |
Est. completion date | March 31, 2031 |
Est. primary completion date | March 31, 2031 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must be able to provide written informed consent form (ICF) - Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish - AML patients must be at least 55 years of age at the time of informed consent. - MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent. Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients: - Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval) - Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients: - Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome). - Cohort assignment is confirmed by the site. Central eligibility review is not required. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients: - Patients who have initiated first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF - Cohort assignment is confirmed by site. Central eligibility review is not required. Luspatercept treated patients: - Patient must have been at least 18 years of age at the start of luspatercept. - Among LR-MDS patients, patient must have initiated luspatercept on or after September 1, 2023, must be ESA-naïve and luspatercept must be the first active treatment (as monotherapy or part of a treatment regimen) for their disease. - Among all other myeloid malignancies, there is no date restriction for initiation of luspatercept .Patient may have received prior treatment for their disease. - Patient must have at least 3 months of follow-up from start of luspatercept treatment at the participating site. Exclusion Criteria: - Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype - Currently enrolled in any interventional clinical trial where the patient is being treated with an investigational product that cannot be identified. - Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy for the treatment of MDS prior to the date of informed consent. - Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent. - Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients with suspected juvenile myelomonocytic leukemia (JMML). Luspatercept treated patients: - Patient must not be currently or previously enrolled in the Connect Myeloid Registry. - Patient must not have received luspatercept as part of a clinical trial. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Puerto Rico Hematology Oncology Group | Bayamon | |
Puerto Rico | Fundacion de lnvestigaci6n | San Juan | |
Puerto Rico | VA Caribbean Healthcare System CRADA | San Juan | |
United States | Hendrick Cancer Center | Abilene | Texas |
United States | Summa Health System | Akron | Ohio |
United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
United States | BSL Health System (Harrington Cancer Center) | Amarillo | Texas |
United States | Texas Oncology, Amarillo Cancer Center | Amarillo | Texas |
United States | McFarland Clinic, P.C | Ames | Iowa |
United States | St. Vincent Anderson Regional Hospital Research | Anderson | Indiana |
United States | University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce | Ann Arbor | Michigan |
United States | Ashland-Bellefonte Cancer Center | Ashland | Kentucky |
United States | Emory University | Atlanta | Georgia |
United States | Piedmont Cancer Institute, P.C. (was Peachtree Hematology-Oncology Consultants) | Atlanta | Georgia |
United States | Georgia Regents University Cancer Center | Augusta | Georgia |
United States | Togus Va Medical Center | Augusta | Minnesota |
United States | Comprehensive Blood & Cancer Center | Bakersfield | California |
United States | Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center (Baton Rouge) | Baton Rouge | Louisiana |
United States | Our Lady of the Lake Physician Group-Medical Oncology | Baton Rouge | Louisiana |
United States | PeaceHealth St Joseph Cancer Center | Bellingham | Washington |
United States | Alta Bates Summit Comprehensive Cancer | Berkeley | California |
United States | Sutter East Bay Hospitals (dba Jordan Research and Education Institute - REDI) | Berkeley | California |
United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
United States | Billings Clinic | Billings | Montana |
United States | St. Vincent Frontier Cancer Center | Billings | Montana |
United States | IU health Bloomington Hospital | Bloomington | Indiana |
United States | Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | MCDA - Central Care Center | Bolivar | Missouri |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | University Cancer Institute | Boynton Beach | Florida |
United States | Albert Einstein College of Medicine - Montefiore Medical Center | Bronx | New York |
United States | New York Cancer and Blood Specialists | Bronx | New York |
United States | Maimonides Cancer Center | Brooklyn | New York |
United States | Southeast Georgia Health System | Brunswick | Georgia |
United States | Gabrail Cancer Center Research | Canton | Ohio |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Charleston Hematology Oncology Associates, PA | Charleston | South Carolina |
United States | Memorial Hospital of Laramie County dba Cheyenne Regional Medical Center | Cheyenne | Wyoming |
United States | Hektoen Inst for Medical Resrch on behalf of itself and John H Stroger Hosp | Chicago | Illinois |
United States | RUSH University Cancer Center | Chicago | Illinois |
United States | Delaware Clinical and Laboratory Physicians | Christiana | Delaware |
United States | TriHealth, Good Samaritan Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Local Institution - 1088 | Cleveland | Ohio |
United States | University Hospitals, Case Medical Center | Cleveland | Ohio |
United States | Boone Hospital Center | Columbia | Michigan |
United States | Harry S Truman Memorial Veterans' Hospital | Columbia | Missouri |
United States | Maryland Oncology Hematology | Columbia | Maryland |
United States | Columbus Regional Research Institute | Columbus | Georgia |
United States | Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center | Columbus | Ohio |
United States | John Muir Clinical Research Center | Concord | California |
United States | Bassett Heathcare Network | Cooperstown | New York |
United States | Christus Spohn Cancer Center | Corpus Christi | Texas |
United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
United States | Good Samaritan Hospital Corvallis | Corvallis | Oregon |
United States | Mary Bird Perkins Cancer Center at St. Tammany | Covington | Louisiana |
United States | QCCA - Pontchartrain Cancer Center | Covington | Louisiana |
United States | Western Maryland Health System | Cumberland | Maryland |
United States | Dallas VA Medical Center | Dallas | Texas |
United States | HOLD - Texas Oncology, Dallas | Dallas | Texas |
United States | Texas Oncology - Sammons Cancer Center | Dallas | Texas |
United States | Halifax Health Center for Oncology | Daytona Beach | Florida |
United States | Oakwood Healthcare Inc. | Dearborn | Michigan |
United States | Saint Joseph Hospital, Cancer Centers of Colorado | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | John D. Dingell VA Medical Center /Cynthia Marbury | Detroit | Michigan |
United States | Consultants in Medical Oncology and Hematology | Drexel Hill | Pennsylvania |
United States | Essentia Health Oncology Clinical Trials | Duluth | Minnesota |
United States | Hematology and Oncology Assoc of NEPA | Dunmore | Pennsylvania |
United States | Hematology Oncology Associates of Central NY | East Syracuse | New York |
United States | Southdale Cancer Clinic | Edina | Minnesota |
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Detroit Clinical Research Center | Farmington Hills | Michigan |
United States | Highlands Oncology Group | Fayetteville | Arkansas |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Broward Oncology Associates | Fort Lauderdale | Florida |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Southeast FL Hematology Oncology Grp | Fort Lauderdale | Florida |
United States | Mercy Hospital Fort Smith | Fort Smith | Arkansas |
United States | Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas |
United States | Robert A. Moss, M.D.,F AC.P, Inc | Fountain Valley | California |
United States | VA Central California Health Care System | Fresno | California |
United States | University of Florida | Gainesville | Florida |
United States | UTMB Galveston | Galveston | Texas |
United States | Central Care Cancer Center | Garden City | Kansas |
United States | C.R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York |
United States | Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan |
United States | Bellin Memorial Hospital/ Bellin Cancer Team | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Marin Cancer Care | Greenbrae | California |
United States | Leo W Jenkins Cancer Center | Greenville | North Carolina |
United States | Prisma Health Cancer Institute - Upstate | Greenville | South Carolina |
United States | Ascension St. John Hospital_Hematology (was St. Johns Hospital and Hematology-Oncology Associates East PC ) | Grosse Pointe Woods | Michigan |
United States | John Theurer Cancer Center (Hackensack U Med Center) | Hackensack | New Jersey |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi |
United States | DuPage Medical Group - Oncology (University of Rodchester) | Hinsdale | Illinois |
United States | Genesis Cancer Center | Hot Springs | Arkansas |
United States | Huntington Medical Group | Huntington Station | New York |
United States | ONCOLOGY SPECIALTIES, PC - Clearview Cancer Institute | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Cancer Specialists of North Florida | Jacksonville | Florida |
United States | University of Florida College of Medicine | Jacksonville | Florida |
United States | Columbia Comprehensive Cancer Care Clinic | Jefferson City | Missouri |
United States | Local Institution - 1047 | Johnson City | New York |
United States | Joliet Oncology Hematology Associates Ltd | Joliet | Illinois |
United States | Local Institution - 1145 | Joliet | Illinois |
United States | Clopton Clinic of Jonesboro, Inc. | Jonesboro | Arkansas |
United States | Local Institution - 1161 | Jonesboro | Arkansas |
United States | NEABC- Fowler Family Center for Cancer Care | Jonesboro | Arkansas |
United States | Mercy Cancer Center - Joplin | Joplin | Missouri |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kansas City Veterans Affairs Medical Center | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Kadlec Regional Medical Center (KRMC) | Kennewick | Washington |
United States | Dayton Physicians | Kettering | Ohio |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
United States | University of Tennessee Medical Center Cancer Intitute | Knoxville | Tennessee |
United States | Gundersen Lutheran Inc | La Crosse | Wisconsin |
United States | UCSD Moores Cancer Center | La Jolla | California |
United States | Horizon Oncology Research, Inc | Lafayette | Indiana |
United States | Watson Clinic Center for Cancer Care and Research | Lakeland | Florida |
United States | Lancaster Cancer Center | Lancaster | Pennsylvania |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Michigan State University/Breslin Cancer Center | Lansing | Michigan |
United States | Oncology and Hematology of South Texas, PA | Laredo | Texas |
United States | Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Cancer and Blood Disease Center | Lecanto | Florida |
United States | Maine Research Associates/Central Maine Medicine | Lewiston | Maine |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
United States | CARTI | Little Rock | Arkansas |
United States | Baptist Health Systems, Inc., DBA Baptist | Louisville | Kentucky |
United States | Southwest Cancer Treatment & Research Center | Lubbock | Texas |
United States | Lynchburg Hematology Oncology Clinic | Lynchburg | Virginia |
United States | Regional Cancer Care Associates | Manchester | Connecticut |
United States | VA Medical Center Manchester | Manchester | New Hampshire |
United States | Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia |
United States | Texas Oncology, McAllen (plus 2 satelite sites) | McAllen | Texas |
United States | Regional One Health | Memphis | Tennessee |
United States | Texas Oncology, Midland | Midland | Texas |
United States | Columbia St. Mary'S | Milwaukee | Wisconsin |
United States | Froedtert & Medical College of Wisconsin CLCC | Milwaukee | Wisconsin |
United States | Montana Cancer Institute Foundation | Missoula | Montana |
United States | Pacific Cancer Care | Monterey | California |
United States | West Virginia University | Morgantown | West Virginia |
United States | Hematology-Oncology Associates of Northern New Jersey | Morristown | New Jersey |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Floyd Memorial Cancer Center of Indiana | New Albany | Indiana |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | Weill Cornell Medical College | New York | New York |
United States | Oncology Hematology Associates of Southwest Indiana | Newburgh | Indiana |
United States | Peninsula Cancer Institute | Newport News | Virginia |
United States | Oncology Specialists, SC | Niles | Illinois |
United States | Ocala Oncology | Ocala | Florida |
United States | Community Cancer Trials of Utah | Ogden | Utah |
United States | INTEGRIS Cancer Institute of Oklahoma Proton Campus | Oklahoma City | Oklahoma |
United States | INTEGRIS Cancer Institute Southwest Medical Center | Oklahoma City | Oklahoma |
United States | Vista Oncology Inc. PS | Olympia | Washington |
United States | 21st Century Oncology | Orange Park | Florida |
United States | Adventist Health System/Sunbelt, Inc. | Orlando | Florida |
United States | St Joseph Healthcare System | Paterson | New Jersey |
United States | Memorial Healthcare System | Pembroke Pines | Florida |
United States | Sacred Heart Medical Oncology Group | Pensacola | Florida |
United States | Illinois Cancer Care | Peoria | Illinois |
United States | Arizona Oncology | Phoenix | Arizona |
United States | Allegheny Singer Research Institute (was West Penn Hospital) | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | HealthCare Alliance (UHA) | Pleasanton | California |
United States | Local Institution - 1131 | Portland | Oregon |
United States | Providence Cancer Center | Portland | Oregon |
United States | Roger Williams Medical Center | Providence | Rhode Island |
United States | Quincy Medical Group | Quincy | Illinois |
United States | Wheaton Franciscan Cancer Care - All Saints | Racine | Wisconsin |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Rochester General Hospital | Rochester | New York |
United States | University of Rochester ~ Wilmot Cancer Institute | Rochester | New York |
United States | Cancer Care Centers of Brevard | Rockledge | Florida |
United States | St. Francis Hospital | Roslyn | New York |
United States | Scott & White Healthcare | Round Rock | Texas |
United States | Foley Cancer Center/RRMC | Rutland | Vermont |
United States | Mercy Cancer Center | Sacramento | California |
United States | Heartland Regional Medical Center (Heartland Health) | Saint Joseph | Missouri |
United States | Local Institution - 1110 | Saint Louis | Missouri |
United States | Mercy Cancer - St. Louis | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Metro MN CCOP/Park Nicollet Institute | Saint Louis Park | Minnesota |
United States | Metro MN CCOP/Park Nicollet Institute | Saint Louis Park | Minnesota |
United States | Salem Health | Salem | Oregon |
United States | Local Institution - 1016 | San Diego | California |
United States | Local Institution - 1027 | Santa Rosa | California |
United States | St Joseph Heritage Healthcare | Santa Rosa | California |
United States | Benaroya Research Institute at Virginia Mason | Seattle | Washington |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | Siouxland Hematology-Oncology Associates | Sioux City | Iowa |
United States | Edward H. KaPlan MD & Associates | Skokie | Illinois |
United States | Orchard Healthcare Research Inc. | Skokie | Illinois |
United States | Somerset Medical Center 110 Rehill Avenue | Somerville | New Jersey |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
United States | St. John Providence Hospital System | Southfield | Michigan |
United States | Sparta Cancer Center | Sparta | New Jersey |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Mercy Research - Springfield | Springfield | Missouri |
United States | Simmons Cancer Institute at Southern Illinois University | Springfield | Illinois |
United States | Bennett Cancer Center Stamford Hospital | Stamford | Connecticut |
United States | St. Joseph's Regional Cancer Center | Stockton | California |
United States | Tallahassee Memorial Cancer Center | Tallahassee | Florida |
United States | Baylor Research Institute dba Scott & White Memorial Hospital | Temple | Texas |
United States | Ashwin Kashyap MD, INC. | Thousand Oaks | California |
United States | Space Coast Medical Associates | Titusville | Florida |
United States | University of Toledo Medical Center (Utmc) | Toledo | Ohio |
United States | Cotton O'Neil Clinical Research/ Stormont Vail Health | Topeka | Kansas |
United States | UM St. Joseph's Medical Center | Towson | Maryland |
United States | Local Institution - 1273 | Tucson | Arizona |
United States | The University of Arizona Cancer Center | Tucson | Arizona |
United States | Oklahoma Cancer Specialist and Research Institute | Tulsa | Oklahoma |
United States | DCH Health System (Lewis and Faye Manderson Cancer Center) | Tuscaloosa | Alabama |
United States | Blood and cancer Center of East Texas | Tyler | Texas |
United States | Carle Cancer Center | Urbana | Illinois |
United States | New York Medical College | Valhalla | New York |
United States | Indian River Memorial Hospital Scully Welsh Cancer Center | Vero Beach | Florida |
United States | Good Samaritan Hospital - Wabash Valley Clinical Research Center | Vincennes | Indiana |
United States | Providence St. Mary Regional Cancer Center | Walla Walla | Washington |
United States | MedStar Health Research Institute (Washington) | Washington | District of Columbia |
United States | Covenant Clinic | Waterloo | Iowa |
United States | Prairie Lakes Health Systen, Inc | Watertown | South Dakota |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | Reading Hospital - McGlinn Cancer Institute | West Reading | Pennsylvania |
United States | Carroll Regional Cancer Center | Westminster | Maryland |
United States | VA Medical Center - White River Junction | White River Junction | Vermont |
United States | Cancer Center of Kansas | Wichita | Kansas |
United States | Ccs Oncology | Williamsville | New York |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
United States | Bond Clinic | Winter Haven | Florida |
United States | Cancer Care Associates of York | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Celgene |
United States, Puerto Rico,
Steensma DP, Abedi M, Bejar R, Cogle CR, Foucar K, Garcia-Manero G, George TI, Grinblatt D, Komrokji R, Ma X, Maciejewski J, Pollyea DA, Savona MR, Scott B, Sekeres MA, Thompson MA, Swern AS, Nifenecker M, Sugrue MM, Erba H. Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study. BMC Cancer. 2016 Aug 19;16:652. doi: 10.1186/s12885-016-2710-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Demographics- MDS/AML/ICUS Cohorts | Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML. | Up to 8 years | |
Primary | Diagnostic and Treatment Patterns- MDS/AML/ICUS Cohorts | Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients with LR or HR MDS, ICUS, and AML | Up to 8 years | |
Primary | Safety and Effectiveness- MDS/AML/ICUS Cohorts | Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events. | Up to 8 years | |
Primary | Patient Demographics- MF Cohort | Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort | Up to 5 years | |
Primary | Diagnostic and Treatment Patterns- MF Cohort | Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients enrolled in the MF Cohort | Up to 5 years | |
Primary | Safety and Effectiveness- MF Cohort | Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events. | Up to 5 years | |
Primary | Treatment effectiveness - LTC | Describe clinical response to treatment, transfusion information, ECOG performance status and deaths. | Minimum of 3-months post index date | |
Primary | Treatment patterns and clinical outcomes - LTC Cohort | Describe the myeloid malignancy treatment patterns and clinical outcomes before and after initiating luspatercept treatment | Minimum of 3-months post index date | |
Primary | Transfusion information - LTC | Describe changes in hemoglobin and transfusion independence status. | Minimum of 3-months post index date | |
Primary | Treatment duration - LTC Cohort | Luspatercept treatment duration | Minimum of 3-months post index date | |
Secondary | Patient Reported Outcome | Summarize patient reported outcomes (including e.g., Health-Related Quality of Life (HRQOL)) and economic outcomes, and their association with patient characteristics, treatment regimens, and clinical outcomes | Up to 8 years | |
Secondary | Correlative Studies | Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples. | Up to 8 years | |
Secondary | Patient demographics and clinical characteristics - LTC | Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept | Baseline | |
Secondary | Reason for treatment discontinuation - LTC | Describe reasons for luspatercept treatment discontinuation | Minimum of 3-months post index date |
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