Trials Sponsors Conditions Drugs Pricing

Conditions

Leukemia, Myeloid, Acute Myelodysplastic Syndromes Primary Myelofibrosis

Keywords

Myelodysplastic syndromesMDSAcute myeloid leukemiaAMLRegistryConnect®ICUSIdiopathic Cytopenias of Undetermined SignificanceMyelofibrosisMFMyelodysplastic/Myeloproliferative overlap syndromesMDS/MPN overlap syndromes

Outcome Measures

Primary Outcomes (10)

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

Study Arms (7)

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

Interventions

LuspaterceptDrug

Prescribed by treating physician as per product label.

Luspatercept treated cohort (LTC)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Patients must be able to provide written informed consent form (ICF)

Sponsors & Collaborators

Celgene
Industrylead

Study Sites (158)

DCH Health System (Lewis and Faye Manderson Cancer Center)

Tuscaloosa, Alabama, 35404, United States

Arizona Oncology

Phoenix, Arizona, 85016, United States

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Local Institution - 1273

Tucson, Arizona, 85724-5024, United States

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Clopton Clinic of Jonesboro, Inc.

Jonesboro, Arkansas, 72401, United States

NEABC- Fowler Family Center for Cancer Care

Related Publications (2)

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.
PMID: 27538433BACKGROUND
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.
PMID: 37517825

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Primary MyelofibrosisMyelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Officials

Bristol-Myers Squibb
Bristol-Myers Squibb
STUDY DIRECTOR

Enrollment

2,013 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 8 Years
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 19, 2012

Study Start

December 12, 2013

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (10)

Study Arms (7)

Newly diagnosed Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Newly diagnosed Higher-Risk Myelodysplastic Syndromes (HR-MDS)

Newly diagnosed Acute Myeloid Leukemia (AML)

Treated Myelofibrosis (MF)

Newly diagnosed Idiopathic cytopenia of undetermined significance (ICUS)

Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (158)

Related Publications (2)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (4)

Luspatercept treated cohort (LTC)

You may not qualify if:

Data Sharing

Source record

Locations