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Chemokine Receptor Antagonist
Reparixin for Myelofibrosis
Phase 2
Recruiting
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 end of study (24 weeks) plus 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess the safety and effectiveness of Reparixin in treating patients with intermediate-2 or high-risk primary myelofibrosis, post ET/PV myelofibrosis, or who are ineligible/refuse treatment with JAKi. 26 patients will be enrolled and receive Reparixin 3x/day for 6 cycles (24 wks). Continued treatment if SD is met.
Who is the study for?
This trial is for adults with intermediate-2 or high-risk primary myelofibrosis, post-ET/PV MF who have not responded well to JAK inhibitor treatment or can't take it. Participants should be in good enough health to perform daily activities with minimal assistance (ECOG ≤ 2), have proper organ function, and a life expectancy of at least six months. Pregnant women and those with recent severe heart issues, active serious infections, or other unstable conditions are excluded.
What is being tested?
The study tests the efficacy and safety of Reparixin taken orally three times daily over a 24-week period in patients with certain types of myelofibrosis after previous treatments have failed. The trial aims to enroll 26 patients who may continue treatment if they show no disease progression after the initial cycles.
What are the potential side effects?
While specific side effects for Reparixin are not listed here, common side effects from drugs treating similar conditions include digestive issues like nausea and diarrhea, potential liver enzyme changes, fatigue, risk of infection due to weakened immune systems, bleeding complications such as hematoma or hemorrhage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study (24 weeks) plus 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (24 weeks) plus 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of reparixin treatment per IWG/ELN criteria
Secondary study objectives
Bone marrow fibrosis grade
Change in Spleen Volume
Number of Adverse Events
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ReparixinExperimental Treatment1 Intervention
Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks). After cycle 6, patients may continue receiving reparixin once daily on a 4-week cycle if at least stable disease (SD) is met by IWG-MRT criteria until loss of response, disease progression, unacceptable toxicity, patient/physician withdrawal, or termination of study by sponsor.
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Who is running the clinical trial?
Dompé Farmaceutici S.p.AIndustry Sponsor
51 Previous Clinical Trials
4,365 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,795 Total Patients Enrolled
4 Trials studying Primary Myelofibrosis
1,626 Patients Enrolled for Primary Myelofibrosis
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,581 Total Patients Enrolled
9 Trials studying Primary Myelofibrosis
1,278 Patients Enrolled for Primary Myelofibrosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stem cell transplant less than 100 days ago.It has been over two weeks since my last myelofibrosis treatment.I haven't used any experimental drugs or devices in the last 4 weeks.I have moderate or severe heart disease.I am currently dealing with a serious infection.My stomach or intestines have issues that could affect how a medicine is absorbed.I am not pregnant or breastfeeding.I am able to get out of my bed or chair and move around.I have recovered from previous cancer treatment side effects, except for hair loss.My condition is a type of advanced myelofibrosis diagnosed by specific criteria.My organs are functioning well.I am 18 years old or older.I have not had a heart attack or stroke in the last 6 months.I do not have any serious health or mental conditions that would stop me from joining the study.I have a history of HIV or active hepatitis A, B, or C.I am willing to have a bone marrow biopsy or had one in the last 90 days without any treatments in between.My condition did not improve with JAK inhibitor therapy.I haven't had any cancer except for skin, prostate, or cervical cancer in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Reparixin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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