Evaluation of the Pathobiology of CALR-mutated MPN Cells

Recruiting

• Conditions: Myeloproliferative Neoplasm
• Interventions: Other: Blood Draw

• Registration Number: NCT06480591
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-06-28
• Status Verified: 2025-01
• Study Start: 2025-01-21
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JAK2 V617F mutation positive MPN patients	Blood Draw	Patients with MPN disease with a JAK2 mutation
CALR-mutation positive patients	Blood Draw	Patients with MPN disease with a CALR mutation

Primary Outcome Measures

Name	Time	Method
Expression levels of TLR 2 and TLR 4	24 months	Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.

Secondary Outcome Measures

Name	Time	Method
Plasma levels of inflammatory cytokines	24 months	Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be recorded by multiplex Elisa for each participant.
History of thrombosis	24 months	Determined for each participant as a binary variable indicating whether this participant had history of thrombosis.
Plasma levels of inflammatory cytokines following incorporation of TLR ligands	24 months	Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be calculated for each participant using the in vitro cell culture system.

Trial Locations

Locations (2)

Atrium Health Levine Cancer; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States