Connect® Myeloid Disease Registry

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.

Study Overview

• Status: Terminated
• Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Primary Myelofibrosis
• Intervention / Treatment: Drug: Luspatercept

Detailed Description

This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.

• Study Type: Observational
• Enrollment (Actual): 2013

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Puerto Rico Hematology Oncology Group
  • San Juan, Puerto Rico, 00683
    • VA Caribbean Healthcare System CRADA
  • San Juan, Puerto Rico, 00927
    • Fundacion de lnvestigaci6n
• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • DCH Health System (Lewis and Faye Manderson Cancer Center)
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85724-5024
      • Local Institution - 1273
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Jonesboro, Arkansas, United States, 72401
      • Clopton Clinic of Jonesboro, Inc.
    • Jonesboro, Arkansas, United States, 72401
      • NEABC- Fowler Family Center for Cancer Care
    • Jonesboro, Arkansas, United States, 72405
      • Local Institution - 1161
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood & Cancer Center
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Comprehensive Cancer
    • Berkeley, California, United States, 94705
      • Sutter East Bay Hospitals (dba Jordan Research and Education Institute - REDI)
    • Concord, California, United States, 94520
      • John Muir Clinical Research Center
    • Fresno, California, United States, 93703-2223
      • VA Central California Health Care System
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
    • Monterey, California, United States, 93940
      • Pacific Cancer Care
    • San Diego, California, United States, 92093-0987
      • Local Institution - 1016
    • Santa Rosa, California, United States, 95403
      • Local Institution - 1027
    • Stockton, California, United States, 95204
      • St. Joseph's Regional Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Saint Joseph Hospital, Cancer Centers of Colorado
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • Regional Cancer Care Associates
    • Stamford, Connecticut, United States, 06904
      • Bennett Cancer Center Stamford Hospital
  • Delaware
    • Christiana, Delaware, United States, 19702
      • Delaware Clinical and Laboratory Physicians
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute
    • Daytona Beach, Florida, United States, 32114
      • Halifax Health Center for Oncology
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Gainesville, Florida, United States, 32610-0278
      • University of Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Cancer Care and Research
    • Ocala, Florida, United States, 34474
      • Ocala Oncology
    • Orlando, Florida, United States, 32804
      • Adventist Health System/Sunbelt, Inc.
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Healthcare System
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Medical Oncology Group
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University Cancer Center
    • Brunswick, Georgia, United States, 31520
      • Southeast Georgia Health system
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, P.C.
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Regional Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Cancer Center
    • Evanston, Illinois, United States, 60659
      • Northshore University Health System
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology Hematology Associates Ltd
    • Joliet, Illinois, United States, 60435
      • Local Institution - 1145
    • Peoria, Illinois, United States, 61615-7828
      • Illinois Cancer Care
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
    • Skokie, Illinois, United States, 60076
      • Edward H. Kaplan MD & Associates
    • Springfield, Illinois, United States, 62702
      • Simmons Cancer Institute at Southern Illinois University
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. Vincent Anderson Regional Hospital Research
    • Bloomington, Indiana, United States, 47402
      • IU health Bloomington Hospital
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Research, Inc
  • Iowa
    • Ames, Iowa, United States, 50010-3014
      • McFarland Clinic, P.C
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology-Oncology Associates
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Central Care Cancer Center
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research/ Stormont Vail Health
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Mary Bird Perkins Cancer Center at St. Tammany
    • Covington, Louisiana, United States, 70433
      • QCCA - Pontchartrain Cancer Center
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology
    • Cumberland, Maryland, United States, 21502
      • Western Maryland Health System
    • Westminster, Maryland, United States, 21157
      • Carroll Regional Cancer Center
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • John D. Dingell VA Medical Center /Cynthia Marbury
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Cancer and Hematology Centers of Western Michigan
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Ascension St. John Hospital_Hematology (was St. Johns Hospital and Hematology-Oncology Associates East PC )
    • Lansing, Michigan, United States, 48910
      • Michigan State University/Breslin Cancer Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Oncology Clinical Trials
    • Edina, Minnesota, United States, 55435
      • Southdale Cancer Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro MN CCOP/Park Nicollet Institute
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro MN CCOP/Park Nicollet Institute
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • MCDA - Central Care Center
    • Cape Girardeau, Missouri, United States, 63703
      • Southeast Cancer Center
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center
    • Columbia, Missouri, United States, 65201
      • Harry S Truman Memorial Veterans' Hospital
    • Joplin, Missouri, United States, 64804
      • Mercy Cancer Center - Joplin
    • Kansas City, Missouri, United States, 64128
      • Kansas City Veterans Affairs Medical Center
    • Saint Joseph, Missouri, United States, 64507
      • Heartland Regional Medical Center (Heartland Health)
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Saint Louis, Missouri, United States, 63131
      • Local Institution - 1110
    • Springfield, Missouri, United States, 65804
      • Mercy Research - Springfield
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Cancer Center
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • VA Medical Center Manchester
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center (Hackensack U Med Center)
    • New Brunswick, New Jersey, United States, 08859
      • Saint Peter's University Hospital
    • Paterson, New Jersey, United States, 07503
      • St Joseph Healthcare System
    • Somerville, New Jersey, United States, 08876
      • Somerset Medical Center 110 Rehill Avenue
    • Sparta, New Jersey, United States, 07871
      • Sparta Cancer Center
  • New York
    • Bronx, New York, United States, 10469
      • New York Cancer and Blood Specialists
    • Cooperstown, New York, United States, 13326
      • Bassett Heathcare Network
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central NY
    • Huntington Station, New York, United States, 11746
      • Huntington Medical Group
    • Johnson City, New York, United States, 13790
      • Local Institution - 1047
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Leo W Jenkins Cancer Center
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialists
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals, Case Medical Center
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 1088
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center (Utmc)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73142
      • INTEGRIS Cancer Institute of Oklahoma Proton Campus
    • Oklahoma City, Oklahoma, United States, 73109
      • INTEGRIS Cancer Institute Southwest Medical Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialist and Research Institute
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Center
    • Portland, Oregon, United States, 97213
      • Local Institution - 1131
    • Salem, Oregon, United States, 97305
      • SALEM Health
  • Pennsylvania
    • Dunmore, Pennsylvania, United States, 18512
      • Hematology and Oncology Assoc of NEPA
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Lancaster, Pennsylvania, United States, 17554
      • Lancaster Cancer Center
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital - McGlinn Cancer Institute
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger Williams Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Upstate
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Health Systen, Inc
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center Cancer Intitute
    • Memphis, Tennessee, United States, 38163
      • Regional One Health
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Cancer Center
    • Amarillo, Texas, United States, 79106
      • Texas Oncology, Amarillo Cancer Center
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Sammons Cancer Center
    • Dallas, Texas, United States, 75230
      • HOLD - Texas Oncology, Dallas
    • Laredo, Texas, United States, 78041
      • Oncology and Hematology of South Texas, PA
    • Lubbock, Texas, United States, 79415
      • Southwest Cancer Treatment & Research Center
    • McAllen, Texas, United States, 78503
      • Texas Oncology, McAllen (plus 2 satelite sites)
    • Round Rock, Texas, United States, 78665
      • Scott & White Healthcare
    • Temple, Texas, United States, 76508
      • Baylor Research Institute dba Scott & White Memorial Hospital
  • Utah
    • Ogden, Utah, United States, 84403
      • Community Cancer Trials of Utah
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • VA Medical Center - White River Junction
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg Hematology Oncology Clinic
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth St Joseph Cancer Center
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Kennewick, Washington, United States, 99336
      • Kadlec Regional Medical Center (KRMC)
    • Olympia, Washington, United States, 98502
      • Vista Oncology Inc. PS
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Walla Walla, Washington, United States, 99362
      • Providence St. Mary Regional Cancer Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • St. Vincent Hospital
    • Green Bay, Wisconsin, United States, 54313
      • Bellin Memorial Hospital/ Bellin Cancer Team
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Inc
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia St. Mary's
    • Racine, Wisconsin, United States, 53405
      • Wheaton Franciscan Cancer Care - All Saints
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Approximately 2,300 adult patients diagnosed with myeloid disease will be enrolled in Connect® Myeloid Registry from 200 sites (both community [70-80%] and academic [20-30%] facilities) across the US that are representative of where patients with myeloid diseases are diagnosed and treated.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newly diagnosed Lower-Risk Myelodysplastic Syndromes (LR-MDS); Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Newly diagnosed Higher-Risk Myelodysplastic Syndromes (HR-MDS); Newly diagnosed higher risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Newly diagnosed Acute Myeloid Leukemia (AML); Newly diagnosed AML patients (≥55 years old, excluding patients with acute promyelocytic leukemia (APL).
Treated Myelofibrosis (MF); Newly treated MF patients receiving treatment for MF or MF-related cytopenias. This cohort also includes patients with myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) overlap syndromes, excluding juvenile myelomonocytic leukemia (JMML).
Newly diagnosed Idiopathic cytopenia of undetermined significance (ICUS); Newly diagnosed ICUS patients.
Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS); Treated LR-MDS patients receiving first active treatment regimen containing at least one non-ESA therapy
Luspatercept treated cohort (LTC); Participants that have initiated luspatercept treatment for a myeloid malignancy.	Drug: Luspatercept; Prescribed by treating physician as per product label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Treatment effectiveness - LTC	Describe clinical response to treatment, transfusion information, ECOG performance status and deaths.	Minimum of 3-months post index date
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
Transfusion information - LTC	Describe changes in hemoglobin and transfusion independence status.	Minimum of 3-months post index date
Treatment duration - LTC Cohort	Luspatercept treatment duration	Minimum of 3-months post index date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Correlative Studies	Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.	Up to 8 years
Patient demographics and clinical characteristics - LTC	Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept	Baseline
Reason for treatment discontinuation - LTC	Describe reasons for luspatercept treatment discontinuation	Minimum of 3-months post index date

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2013
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimated): September 19, 2012

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: AML; Myelofibrosis; Registry; Connect®; MDS; MF; Acute myeloid leukemia; Myelodysplastic syndromes; ICUS; Idiopathic Cytopenias of Undetermined Significance; Myelodysplastic/Myeloproliferative overlap syndromes; MDS/MPN overlap syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Disease; Hematologic Diseases; Precancerous Conditions; Bone Marrow Diseases; Myeloproliferative Disorders; Syndrome; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Primary Myelofibrosis; Hematinics; Luspatercept
• Other Study ID Numbers: AZA-MDS-006; Connect® MDS/AML Registry (Other Identifier: BMS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No