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Primary MyelofibrosisNCT01688011

Connect® Myeloid Disease Registry

An observational study of Primary Myelofibrosis and Myelodysplastic Syndromes, run by Celgene at 158 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Luspatercept
How many people
2,013 participants
Where
158 sitesin 2 countries
Study dates
12 Dec 2013to 18 Oct 2024
How long will I take part?
8 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

158 sites in 2 countries.

158 sites in 2 countries

United States155 sites

  • Hendrick Cancer Center

    Abilene, Texas, 79601

  • Summa Health System

    Akron, Ohio, 44304

  • Texas Oncology, Amarillo Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic, P.C

    Ames, Iowa, 50010-3014

  • St. Vincent Anderson Regional Hospital Research

    Anderson, Indiana, 46016

  • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce

    Ann Arbor, Michigan, 48109

  • Georgia Regents University Cancer Center

    Augusta, Georgia, 30912

  • Comprehensive Blood & Cancer Center

    Bakersfield, California, 93309

  • PeaceHealth St Joseph Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Summit Comprehensive Cancer

    Berkeley, California, 94704

  • Sutter East Bay Hospitals (dba Jordan Research and Education Institute - REDI)

    Berkeley, California, 94705

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • IU health Bloomington Hospital

    Bloomington, Indiana, 47402

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • MCDA - Central Care Center

    Bolivar, Missouri, 65613

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • Southeast Georgia Health System

    Brunswick, Georgia, 31520

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • RUSH University Cancer Center

    Chicago, Illinois, 60612

  • Delaware Clinical and Laboratory Physicians

    Christiana, Delaware, 19702

  • University Hospitals, Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Local Institution - 1088

    Cleveland, Ohio, 44195

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

  • Boone Hospital Center

    Columbia, Missouri, 65201

  • Harry S Truman Memorial Veterans' Hospital

    Columbia, Missouri, 65201

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • John Muir Clinical Research Center

    Concord, California, 94520

  • Bassett Heathcare Network

    Cooperstown, New York, 13326

  • Mary Bird Perkins Cancer Center at St. Tammany

    Covington, Louisiana, 70433

  • QCCA - Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Western Maryland Health System

    Cumberland, Maryland, 21502

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • HOLD - Texas Oncology, Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Sammons Cancer Center

    Dallas, Texas, 75246

  • Halifax Health Center for Oncology

    Daytona Beach, Florida, 32114

  • Saint Joseph Hospital, Cancer Centers of Colorado

    Denver, Colorado, 80218

  • John D. Dingell VA Medical Center /Cynthia Marbury

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Essentia Health Oncology Clinical Trials

    Duluth, Minnesota, 55805

  • Hematology and Oncology Assoc of NEPA

    Dunmore, Pennsylvania, 18512

  • Hematology Oncology Associates of Central NY

    East Syracuse, New York, 13057

  • Southdale Cancer Clinic

    Edina, Minnesota, 55435

  • NorthShore University Health System

    Evanston, Illinois, 60659

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • VA Central California Health Care System

    Fresno, California, 93703-2223

  • University of Florida

    Gainesville, Florida, 32610-0278

  • Central Care Cancer Center

    Garden City, Kansas, 67846

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Bellin Memorial Hospital/ Bellin Cancer Team

    Green Bay, Wisconsin, 54313

  • Leo W Jenkins Cancer Center

    Greenville, North Carolina, 27834

  • Prisma Health Cancer Institute - Upstate

    Greenville, South Carolina, 29605

  • Ascension St. John Hospital_Hematology (was St. Johns Hospital and Hematology-Oncology Associates East PC )

    Grosse Pointe Woods, Michigan, 48236

  • John Theurer Cancer Center (Hackensack U Med Center)

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Huntington Medical Group

    Huntington Station, New York, 11746

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Local Institution - 1047

    Johnson City, New York, 13790

  • Joliet Oncology Hematology Associates Ltd

    Joliet, Illinois, 60435

  • Local Institution - 1145

    Joliet, Illinois, 60435

  • Clopton Clinic of Jonesboro, Inc.

    Jonesboro, Arkansas, 72401

  • NEABC- Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • Local Institution - 1161

    Jonesboro, Arkansas, 72405

  • Mercy Cancer Center - Joplin

    Joplin, Missouri, 64804

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Kadlec Regional Medical Center (KRMC)

    Kennewick, Washington, 99336

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • University of Tennessee Medical Center Cancer Intitute

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Inc

    La Crosse, Wisconsin, 54601

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Horizon Oncology Research, Inc

    Lafayette, Indiana, 47905

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17554

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Michigan State University/Breslin Cancer Center

    Lansing, Michigan, 48910

  • Oncology and Hematology of South Texas, PA

    Laredo, Texas, 78041

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Southwest Cancer Treatment & Research Center

    Lubbock, Texas, 79415

  • Lynchburg Hematology Oncology Clinic

    Lynchburg, Virginia, 24501

  • Regional Cancer Care Associates

    Manchester, Connecticut, 06040

  • VA Medical Center Manchester

    Manchester, New Hampshire, 03104

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Texas Oncology, McAllen (plus 2 satelite sites)

    McAllen, Texas, 78503

  • Regional One Health

    Memphis, Tennessee, 38163

  • Columbia St. Mary'S

    Milwaukee, Wisconsin, 53211

  • Pacific Cancer Care

    Monterey, California, 93940

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08859

  • Weill Cornell Medical College

    New York, New York, 10065

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Ocala Oncology

    Ocala, Florida, 34474

  • Community Cancer Trials of Utah

    Ogden, Utah, 84403

  • INTEGRIS Cancer Institute Southwest Medical Center

    Oklahoma City, Oklahoma, 73109

  • INTEGRIS Cancer Institute of Oklahoma Proton Campus

    Oklahoma City, Oklahoma, 73142

  • Vista Oncology Inc. PS

    Olympia, Washington, 98502

  • Adventist Health System/Sunbelt, Inc.

    Orlando, Florida, 32804

  • St Joseph Healthcare System

    Paterson, New Jersey, 07503

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33028

  • Sacred Heart Medical Oncology Group

    Pensacola, Florida, 32504

  • Illinois Cancer Care

    Peoria, Illinois, 61615-7828

  • Arizona Oncology

    Phoenix, Arizona, 85016

  • Local Institution - 1131

    Portland, Oregon, 97213

  • Providence Cancer Center

    Portland, Oregon, 97213

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Wheaton Franciscan Cancer Care - All Saints

    Racine, Wisconsin, 53405

  • Rochester General Hospital

    Rochester, New York, 14621

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Scott & White Healthcare

    Round Rock, Texas, 78665

  • Heartland Regional Medical Center (Heartland Health)

    Saint Joseph, Missouri, 64507

  • Metro MN CCOP/Park Nicollet Institute

    Saint Louis Park, Minnesota, 55416

  • Metro MN CCOP/Park Nicollet Institute

    Saint Louis Park, Minnesota, 55426

  • Salem Health

    Salem, Oregon, 97305

  • Local Institution - 1016

    San Diego, California, 92093-0987

  • Local Institution - 1027

    Santa Rosa, California, 95403

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Edward H. KaPlan MD & Associates

    Skokie, Illinois, 60076

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Somerset Medical Center 110 Rehill Avenue

    Somerville, New Jersey, 08876

  • Sparta Cancer Center

    Sparta, New Jersey, 07871

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Simmons Cancer Institute at Southern Illinois University

    Springfield, Illinois, 62702

  • Mercy Research - Springfield

    Springfield, Missouri, 65804

  • Local Institution - 1110

    St Louis, Missouri, 63131

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Bennett Cancer Center Stamford Hospital

    Stamford, Connecticut, 06904

  • St. Joseph's Regional Cancer Center

    Stockton, California, 95204

  • Baylor Research Institute dba Scott & White Memorial Hospital

    Temple, Texas, 76508

  • New York Cancer and Blood Specialists

    The Bronx, New York, 10469

  • University of Toledo Medical Center (Utmc)

    Toledo, Ohio, 43614

  • Cotton O'Neil Clinical Research/ Stormont Vail Health

    Topeka, Kansas, 66606

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Local Institution - 1273

    Tucson, Arizona, 85724-5024

  • Oklahoma Cancer Specialist and Research Institute

    Tulsa, Oklahoma, 74146

  • DCH Health System (Lewis and Faye Manderson Cancer Center)

    Tuscaloosa, Alabama, 35404

  • New York Medical College

    Valhalla, New York, 10595

  • Providence St. Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Prairie Lakes Health Systen, Inc

    Watertown, South Dakota, 57201

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Reading Hospital - McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611

  • Carroll Regional Cancer Center

    Westminster, Maryland, 21157

  • VA Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

Other trials in United States

Puerto Rico3 sites

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

  • VA Caribbean Healthcare System CRADA

    San Juan, 00683

  • Fundacion de lnvestigaci6n

    San Juan, 00927

Other trials in Puerto Rico

About this study

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.

Read the 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.

Being tested
Luspatercept
Keywords
Myelodysplastic syndromes, MDS, Acute myeloid leukemia, AML, Registry, Connect®, ICUS, Idiopathic Cytopenias of Undetermined Significance, Myelofibrosis, MF, Myelodysplastic/Myeloproliferative overlap syndromes, MDS/MPN overlap syndromes
Medical subject headings
Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LuspaterceptDrug

    Prescribed by treating physician as per product label.

Study groups in NCT01688011
Study groupRoleWhat they receive
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.
Receives: Drug: Luspatercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Demographics- MDS/AML/ICUS Cohorts

    Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML.

    Measured: Up to 8 years

  2. 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

    Measured: Up to 8 years

  3. 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.

    Measured: Up to 8 years

  4. Patient Demographics- MF Cohort

    Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort

    Measured: Up to 5 years

  5. 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

    Measured: Up to 5 years

  6. 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.

    Measured: Up to 5 years

  7. Treatment effectiveness - LTC

    Describe clinical response to treatment, transfusion information, ECOG performance status and deaths.

    Measured: Minimum of 3-months post index date

  8. Treatment patterns and clinical outcomes - LTC Cohort

    Describe the myeloid malignancy treatment patterns and clinical outcomes before and after initiating luspatercept treatment

    Measured: Minimum of 3-months post index date

  9. Transfusion information - LTC

    Describe changes in hemoglobin and transfusion independence status.

    Measured: Minimum of 3-months post index date

  10. Treatment duration - LTC Cohort

    Luspatercept treatment duration

    Measured: Minimum of 3-months post index date

Secondary outcomes (4)

  1. 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

    Measured: Up to 8 years

  2. Correlative Studies

    Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.

    Measured: Up to 8 years

  3. Patient demographics and clinical characteristics - LTC

    Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept

    Measured: Baseline

  4. Reason for treatment discontinuation - LTC

    Describe reasons for luspatercept treatment discontinuation

    Measured: Minimum of 3-months post index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2012 (estimated)
  2. Study start12 Dec 2013
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,013 participants (actual)
Target duration
8 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688011
Sponsor's protocol ID
AZA-MDS-006
Other IDs
Connect® MDS/AML Registry
Status last verified
Jun 2025
First submitted
14 Sep 2012
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27538433

  • Patel JL, Erba HP, Savona MR, Grinblatt DL, Clark M, Clive TC, Smart TB, Makinde AY, DeGutis IS, Yu E, Eggington JM, George TI. Genomic Data Heterogeneity across Molecular Diagnostic Laboratories: A Real-World Connect Myeloid Disease Registry Perspective on Variabilities in Genomic Assay Methodology and Reporting. J Mol Diagn. 2023 Aug;25(8):611-618. doi: 10.1016/j.jmoldx.2023.05.002.

    PubMed 37517825

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Myelofibrosis and Myelodysplastic Syndromes, run by Celgene at 158 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Demographics- MDS/AML/ICUS Cohorts (time frame: Up to 8 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01688011, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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