Myeloproliferative NeoplasmNCT06480591
Evaluation of the Pathobiology of CALR-mutated MPN Cells
An observational study of Myeloproliferative Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Blood Draw
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.
Who may be able to join
- 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
Who cannot join
- Diagnosis of MPN with JAK2 V617F mutation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Courtney Schepel, (980) 292-0817, Courtney.Schepel@atriumhealth.org
Aleksander Chojecki, MD
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Ruben Mesa, MD, 336-716-4618, ruben.mesa@atriumhealth.org
Ruben Mesa, MD
About this study
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.
Read the 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.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Blood Draw
- Keywords
- Thrombosis, JAK2 mutation, CALR mutation
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.
| Study group | Role | What they receive |
|---|---|---|
| JAK2 V617F mutation positive MPN patients | Patients with MPN disease with a JAK2 mutation Receives: Other: Blood Draw | |
| CALR-mutation positive patients | Patients with MPN disease with a CALR mutation Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of TLR 2 and TLR 4
Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.
Measured: 24 months
Secondary outcomes (3)
Plasma levels of inflammatory cytokines
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.
Measured: 24 months
Plasma levels of inflammatory cytokines following incorporation of TLR ligands
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.
Measured: 24 months
History of thrombosis
Determined for each participant as a binary variable indicating whether this participant had history of thrombosis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start21 Jan 2025
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Brookdale University Hospital Medical Center
- Responsible party
- Sponsor
- Investigators
- Aleksander Chojecki, MD, Principal investigator, Atrium Health Levine Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480591
- Sponsor's protocol ID
- IRB00100615
- Other IDs
- P30CA012197, LCI-HEM-MPN-CALR-001
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Releasing the Individual Participant Data (IPD) is not required to meet the study objectives, and therefore is not planned to be released. Additionally, there is no plan to share data, particularly individual participant data, with anyone who is not already involved in the study
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pathobiology of CALR-mutated MPN Cells
- ClinicalTrials.gov ID
- NCT06480591
- Acronym / sponsor ID
- IRB00100615
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- Thrombosis, JAK2 mutation, CALR mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Brookdale University Hospital Medical Center
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAK2 V617F mutation positive MPN patients | – | Other: Blood DrawPatients with MPN disease with a JAK2 mutation |
| CALR-mutation positive patients | – | Other: Blood DrawPatients with MPN disease with a CALR mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of MPN with JAK2 V617F mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawThe amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons. | Other | CALR-mutation positive patients, JAK2 V617F mutation positive MPN patients |
Primary outcome
Expression levels of TLR 2 and TLR 4
Time frame: 24 months
Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.
3 secondary outcomes
Plasma levels of inflammatory cytokines
Time frame: 24 months
Plasma levels of inflammatory cytokines following incorporation of TLR ligands
Time frame: 24 months
History of thrombosis
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. Releasing the Individual Participant Data (IPD) is not required to meet the study objectives, and therefore is not planned to be released. Additionally, there is no plan to share data, particularly individual participant data, with anyone who is not already involved in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksander Chojecki, MD principal investigator
Atrium Health Levine Cancer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Schepel ((980) 292-0817, Courtney.Schepel@atriumhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of TLR 2 and TLR 4 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.