Evaluation of the Pathobiology of CALR-mutated MPN Cells

NCT ID: NCT06480591

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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This biospecimen study is designed to evaluate the expression levels of TLR 2 and TLR 4 on mononuclear cells in CALR mutation positive MPN participants and compare to JAK2 V617F mutation positive MPN patients and healthy controls. Patients who have MPN with the CALR mutation positive will be approached for interest in participating in this study. A research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. The participant's demographics, MPN subtype, CALR mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. Clinical data will be collected, including results from the CBC with differential, complete metabolic panel (if available), and PT/PTT/INR (if available) drawn closest to the research blood collection. This study will initially open as a single center study at AHWFBCCC.

Conditions

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Myeloproliferative Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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JAK2 V617F mutation positive MPN patients

Patients with MPN disease with a JAK2 mutation

Blood Draw

Intervention Type OTHER

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

CALR-mutation positive patients

Patients with MPN disease with a CALR mutation

Blood Draw

Intervention Type OTHER

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

Interventions

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Blood Draw

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- Diagnosis of MPN with JAK2 V617F mutation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atrium Health Levine Cancer Institute

OTHER

Sponsor Role collaborator

Brookdale University Hospital Medical Center

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksander Chojecki, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Levine Cancer

Locations

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Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Courtney Schepel

Role: CONTACT

(980) 292-0817

Facility Contacts

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Courtney Schepel

Role: primary

980-292-0817

Ruben Mesa, MD

Role: primary

336-716-4618

Other Identifiers

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LCI-HEM-MPN-CALR-001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00100615

Identifier Type: -

Identifier Source: org_study_id

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