Connect® Myeloid Disease Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01688011
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Celgene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Drug: - Luspatercept

Prescribed by treating physician as per product label.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsville, Alabama

Status

Withdrawn

Address

ONCOLOGY SPECIALTIES, PC - Clearview Cancer Institute

Huntsville, Alabama, 35805

Site Contact

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