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Evaluation of the Pathobiology of CALR-mutated MPN Cells
N/A
Waitlist Available
Led By Aleksander Chojecki, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Myeloproliferative Neoplasms
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Expression levels of TLR 2 and TLR 4
Secondary study objectives
History of thrombosis
Plasma levels of inflammatory cytokines
Plasma levels of inflammatory cytokines following incorporation of TLR ligands
Side effects data
From 2017 Phase 2 trial • 14 Patients • NCT0143748864%
Fatigue
43%
Diarrhea
36%
Constipation
36%
Anemia
36%
Nausea
21%
Creatinine Increased
21%
Lightheadedness
21%
Vomiting
21%
Hypokalemia
14%
Abdominal Pain
14%
Back Pain
14%
Dizziness
14%
Fever
14%
Flu-Like symptoms
14%
Hypomagnesia
14%
Pinching sensation around port
14%
Shortness of Breath
14%
URI
14%
Abdominal cramping
14%
Insomnia
14%
Thrombocytopenia
7%
Tearing
7%
Tinnitus
7%
Bloating
7%
Blood in Bilirubin increased
7%
Decreased Appetite
7%
Dry Skin
7%
Sacral Edema
7%
Acid Reflux
7%
INR increased
7%
Embolic stroke
7%
Pulmonary Embolism
7%
Anorexia
7%
Anxiety
7%
Dyspnea
7%
Dysuria
7%
Fall
7%
Flatulence
7%
Foot Pain
7%
Hematoma
7%
Leg pain
7%
Loose Stools
7%
mild-mod Congestion
7%
Neutrophil count decreased
7%
Neuropathy
7%
Rib pain
7%
Throat discomfort
7%
Urinary incontinence
7%
Urinary Tract Obstruction
7%
Worsening pain
7%
Vision changes
7%
Hypoxia
7%
Abdominal distention
7%
Alkalosis
7%
Bladder Spasm
7%
Blurred Vision
7%
Bone Pain
7%
Cabazitaxel Infusion reaction
7%
Change in Taste
7%
Epigastric Pain
7%
Hematuria
7%
Hypophosphatemia
7%
Hypertension
7%
Pain in Pelvis
7%
Paresthesia bilateral feet
7%
Perioral numbness
7%
Peripheral Neuropathy
7%
Weakness
7%
Weight loss
7%
Tachycardia
7%
Bleeding Gums
7%
PTT prolonged
7%
Pyelonephritis
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: JAK2 V617F mutation positive MPN patientsExperimental Treatment1 Intervention
Patients with MPN disease with a JAK2 mutation
Group II: CALR-mutation positive patientsExperimental Treatment1 Intervention
Patients with MPN disease with a CALR mutation
Find a Location
Who is running the clinical trial?
Brookdale University Hospital Medical CenterOTHER
8 Previous Clinical Trials
3,163 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,300 Total Patients Enrolled
Atrium Health Levine Cancer InstituteOTHER
27 Previous Clinical Trials
3,758 Total Patients Enrolled
Aleksander Chojecki, MDPrincipal InvestigatorAtrium Health Levine Cancer
1 Previous Clinical Trials
120 Total Patients Enrolled