Clinical trial · Observational
Connect® Myeloid Disease Registry
Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Primary Myelofibrosis | Primary Myelofibrosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luspatercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Newly diagnosed Lower-Risk Myelodysplastic Syndromes (LR-MDS)
- description
- Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).
- label
- Newly diagnosed Higher-Risk Myelodysplastic Syndromes (HR-MDS)
- description
- Newly diagnosed higher risk MDS patients as determined by International Prognostic Scoring System (IPSS).
- label
- Newly diagnosed Acute Myeloid Leukemia (AML)
- description
- Newly diagnosed AML patients (≥55 years old, excluding patients with acute promyelocytic leukemia (APL).
- label
- Treated Myelofibrosis (MF)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDSteensma 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 27538433
- DERIVEDPatel 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