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Registry for patients with myeloid diseases

Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Observational Celgene · NCT01688011

This study is collecting information from patients with myeloid diseases to see how different treatments work and how they affect people's health over time.

Quick facts

Study typeObservational
Enrollment2300 (estimated)
Ages18 Years and up
SexAll
SponsorCelgene Industry-sponsored
Locations240 sites (Huntsville, Alabama and 239 other locations)
Trial IDNCT01688011 on ClinicalTrials.gov

What this trial studies

The Connect® Myeloid Disease Registry aims to gather comprehensive data on treatment decisions and outcomes for patients with myeloid diseases, including primary myelofibrosis, myelodysplastic syndromes, and acute myeloid leukemia. This observational registry will document patient characteristics, treatment patterns, and clinical outcomes in both community and academic settings. By evaluating molecular and cellular markers, the registry seeks to enhance prognostic classification and understand the effectiveness and safety of various treatment regimens. Data will be collected quarterly through electronic case report forms, focusing on treatment responses and patient-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed myeloid diseases such as MDS, AML, or primary myelofibrosis.

Not a fit: Patients with advanced or refractory myeloid diseases who do not meet the eligibility criteria may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights that improve treatment strategies and outcomes for patients with myeloid diseases.

How similar studies have performed: Other disease registries have shown success in improving understanding of treatment patterns and outcomes, suggesting this approach is promising.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Huntsville, Alabama and 239 other locations

+190 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary MyelofibrosisMyelodysplastic SyndromesLeukemia, Myeloid, AcuteMyelodysplastic syndromesMDSAcute myeloid leukemiaAMLRegistry
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.