Is NCT05835466 recruiting in Tampa, FL?

Yes, NCT05835466 is currently recruiting participants at its Tampa, FL location. This myelofibrosis clinical trial is actively enrolling qualified participants.

How do I join the myelofibrosis clinical trial in Tampa?

To join this clinical trial in Tampa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tampa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Myelofibrosis Clinical Trial in Tampa, FL

About This Myelofibrosis Study in Tampa

This is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF) after prior treatment, and those who are ineligible or refuse treatment, with a Janus kinase inhibitor (JAKi). 26 patients will be enrolled. Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study per

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

Be ≥ 18 years of age at time of signing the informed consent form (ICF)

Willing to voluntarily sign the ICF

Have a pathologically confirmed diagnosis of PMF, post-ET-MF, or post-PV-MF as per the World Health Organization (WHO) diagnostic criteria with intermediate-2 or higher risk disease by DIPSS

Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Willing to undergo a bone marrow biopsy at screening o A bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice.

Be refractory/resistant to or intolerant of/inappropriate for JAKi therapy as defined by at least one of the following:

Treatment for ≥ 3 months with inadequate efficacy as demonstrated by persistent palpable splenomegaly ≥ 5cm or symptoms related to splenomegaly,

Treatment for ≥ 28 days complicated by either:

Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months)

CTCAE grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, or hemorrhage while being treated with a JAKi

Development of non-hematological toxicity that makes patient intolerant of JAKi therapy

In the Investigator's judgment, are not candidates for available approved JAKi

Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia

At least two weeks must have elapsed between the last dose of any MF-directed drug treatments or other investigational therapies and start of reparixin o Participants may continue hydroxyurea until the day prior to C1D1 if needed for disease control

Have adequate organ function as demonstrated by the following:

ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to MF-related EMH);

Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to MF-related EMH or documented Gilbert's syndrome);

Creatinine clearance ≥ 40 mL/min;

Platelet count ≥ 25 x 109/L;

Bone marrow and peripheral blood blast count \< 10%;

ANC ≥ 1000 mm3.

Life expectancy of at least six months

Women of childbearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days following completion of therapy. WCBP must also have a negative serum pregnancy test at screening and Cycle 1 Day 1. Should a woman become pregnant or suspect she is pregnant while participating, she should inform her treating physician immediately. (Section 5.9.2) o Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 120 days after the last dose of study therapy

Ability to adhere to the study visit schedule and all protocol requirements

Exclusion Criteria

History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months

Other invasive malignancies within the last 3 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer

Moderate or severe cardiovascular disease meeting one or both of the below criteria:

Presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension

Documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments)

Presence of active serious infection

Any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the ICF or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Participants who have undergone a hematopoietic cell transplant (HCT) within 100 days of the first dose of study therapy, participants on immunosuppressive therapy post-HCT at screening, use of calcineurin inhibitors within 4 weeks prior to first dose of study therapy, or participants with clinically significant graft-versus-host disease (GVHD) o Note: The use of topical steroids or \< 10mg oral prednisone for ongoing skin GVHD is permitted

Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection

Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of reparixin, including any unresolved nausea, vomiting, or diarrhea \> CTCAE grade 1

Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective institutional review board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific participant

Organ transplant recipients other than bone marrow transplant

Women who are pregnant or lactating

History of splenectomy

Known hypersensitivity to sulfonamides o Hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does not qualify for exclusion

Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAID), including ibuprofen

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT05835466) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelofibrosis Treatment Options in Tampa, FL

If you're searching for myelofibrosis treatment options in Tampa, FL, this clinical trial (NCT05835466) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced myelofibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelofibrosis clinical trials near you to find additional studies recruiting in your area.

Myelofibrosis Clinical Trial in Tampa, FL

Expert Care in Tampa

IRB Approved

No-Cost Care

Apply for This Tampa Location

Why Participate?

Simple Process