Connect® Myeloid Disease Registry

Description

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

Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Study Overview

Study Details

Study overview

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.

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

Connect® Myeloid Disease Registry

Condition
Primary Myelofibrosis
Intervention / Treatment

-

Contacts and Locations

Huntsville

ONCOLOGY SPECIALTIES, PC - Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Tuscaloosa

DCH Health System (Lewis and Faye Manderson Cancer Center), Tuscaloosa, Alabama, United States, 35404

Phoenix

Arizona Oncology, Phoenix, Arizona, United States, 85016

Tucson

The University of Arizona Cancer Center, Tucson, Arizona, United States, 85719

Tucson

Local Institution - 1273, Tucson, Arizona, United States, 85724-5024

Fayetteville

Highlands Oncology Group, Fayetteville, Arkansas, United States, 72703

Fort Smith

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States, 72903

Hot Springs

Genesis Cancer Center, Hot Springs, Arkansas, United States, 71913

Jonesboro

Clopton Clinic of Jonesboro, Inc., Jonesboro, Arkansas, United States, 72401

Jonesboro

NEABC- Fowler Family Center for Cancer Care, Jonesboro, Arkansas, United States, 72401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • * 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.
  • * 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.
  • * 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.
  • * 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celgene,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-03-31