Evaluation of the Pathobiology of CALR-mutated MPN Cells

NCT06480591 | Recruiting DMC

• 2 other identifiers: IRB00100615LCI-HEM-MPN-CALR-001
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.

Conditions

Myeloproliferative Neoplasm

Keywords

Thrombosis; JAK2 mutation; CALR mutation

Outcome Measures

Primary Outcomes (1)

• Expression levels of TLR 2 and TLR 4

  Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.

  24 months

Secondary Outcomes (3)

• Plasma levels of inflammatory cytokines

  24 months

• Plasma levels of inflammatory cytokines following incorporation of TLR ligands

  24 months

• History of thrombosis

  24 months

Study Arms (2)

JAK2 V617F mutation positive MPN patients

Patients with MPN disease with a JAK2 mutation

Other: Blood Draw

CALR-mutation positive patients

Patients with MPN disease with a CALR mutation

Other: Blood Draw

Interventions

Blood Draw OTHER

The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.

CALR-mutation positive patients; JAK2 V617F mutation positive MPN patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.

You may qualify if:

• Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his/her legally authorized representative (LAR).
• Age ≥ 18 years at the time of enrollment
• Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS/MPNs
• CALR-positive genetic mutation

You may not qualify if:

• \- Diagnosis of MPN with JAK2 V617F mutation

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator
• Brookdale University Hospital Medical Center: collaborator

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aleksander Chojecki, MD

  Atrium Health Levine Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Schepel

CONTACT

(980) 292-0817; Courtney.Schepel@atriumhealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 28, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)