Is NCT06541249 recruiting in New York, NY?

Yes, NCT06541249 is currently recruiting participants at its New York, NY location. This polycythemia vera (pv) clinical trial is actively enrolling qualified participants.

How do I join the polycythemia vera (pv) clinical trial in New York?

To join this clinical trial in New York, 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 New York 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.

Polycythemia Vera (PV) Clinical Trial in New York, NY

About This Polycythemia Vera (PV) Study in New York

Low-dose MTX is a widely used, inexpensive, and safe therapy used for decades and is well tolerated by patients with rheumatologic diseases. Recently, it was identified as a type 2 JAK inhibitor. If MTX proves to be safe and tolerable with a signal of clinical activity, this could have a significant benefit to patients with MPNs. Beyond the potential benefit of adding a type 2 JAK inhibitor to current therapy, this could signal the need to study MTX in MPNs further as a monotherapy. Discovering MTX as safe and clinically effective in MPNs could be profound on both a public health and global health scale for patients who are uninsured and cannot afford more expensive novel JAK inhibitors, or for those in countries where JAK inhibitors are not available. Accordingly, the research team deems it reasonable and prudent to assess the safety and efficacy of MTX in addition to current therapy for patients with MPN. The research team will evaluate patients for spleen responses, symptom responses, and cytologic responses. Correlative data will evaluate pharmacokinetic and disease modifying activity of MTX in MPNs to inform future clinical trials.

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)

Must voluntarily sign ICF and be willing and able to adhere to the study visit schedule and all protocol requirements

Have a pathologically confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF as per WHO diagnostic criteria

Participants with MF may have low, intermediate 1, intermediate 2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS). Participants with PV and ET with both low- and high-risk disease may be included.

Must have received at least 12 weeks of current MPN therapy at stable doses and have persistent clinical burden and/or cytologic abnormalities as defined by the following:

Clinical burden is defined as MPN-SAF TSS \>12 points and/or palpable spleen of ≥5cm

Cytologic abnormalities include the following for each disease state:

Persistent leukocytosis as defined by WBC \>12 x 109/L

Persistent therapeutic phlebotomy dependence (\>2 phlebotomies within 24 weeks of screening, and \>1 phlebotomy within 16 weeks of screening, as defined in the PROUD-PV studies) for a goal HCT \<45% and/or

Leukocytosis as defined by WBC \>12 x 109/L and/or

Thrombocytosis defined as platelet count \>500 x 109/L

Persistent leukocytosis as defined by WBC \>12 x 109/L and/or

Thrombocytosis defined as platelet count \>500 x 109/L

Permitted concurrent MPN therapies include: aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and/or ruxolitinib.

A stable dose is defined as 12 weeks of treatment without a change in dosing

Patients with myelofibrosis must be on stable dose of ruxolitinib

Must have adequate organ function as demonstrated by the following:

AST, ALT \<3x upper limit of normal (ULN) and no known history of cirrhosis

Total bilirubin \<3mg/dL

Creatinine clearance (CrCl) \>40 mL/min as estimated with the Cockcroft-Gault equation

Baseline platelet count \>50 x 109/L for MF and \>150 x 109/L for ET/PV

Baseline absolute neutrophil count (ANC) \>1000

Peripheral blood blast count \<10%

ECOG performance status ≤2

Life expectancy of at least six months

Female participants of childbearing potential must have a negative serum pregnancy test at screening and Cycle 1 Day 1 and must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Recommended methods of birth control are:

The consistent use of an approved hormonal contraception (birth control pill/patches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse), or sterilization

A woman of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal litigation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months

Male participants must agree to use an adequate method of contraception and must not father a child or donate sperm starting with the first dose of study therapy through 120 days after the last dose of study therapy

Exclusion Criteria

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

Prescribed MTX for another indication

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

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

Have moderate or severe cardiovascular disease as defined by the following:

Have 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

Have documented major ECG abnormalities (not responding to medical treatments)

Be an organ transplant recipient other than bone marrow transplant

Presence of active serious infection

Have a known history B, or untreated hepatitis C infection

Have a known history of pulmonary fibrosis, interstitial pneumonitis

Have a known history of chronic pericardial effusions, pleural effusions, or ascites

Have a known history of cirrhosis, or current heavy alcohol consumption

Have impairment of gastrointestinal function or gastrointestinal disease that could significantly alter the absorption of MTX, including any unresolved nausea, vomiting, or diarrhea \> CTCAE v5.0 grade 1

Have known history of tuberculosis or severe fungal infection

Is receiving specific concomitant medications that are contraindicated with MTX.

Women who are pregnant or lactating, or plan to become pregnant during trial period

Have any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the informed consent form 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

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 IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant

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 New York?

Yes, this clinical trial (NCT06541249) has an active research site in New York, NY 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.

Polycythemia Vera (PV) Treatment Options in New York, NY

If you're searching for polycythemia vera (pv) treatment options in New York, NY, this clinical trial (NCT06541249) 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 New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced polycythemia vera (pv) 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 polycythemia vera (pv) clinical trials near you to find additional studies recruiting in your area.

Polycythemia Vera (PV) Clinical Trial in New York, NY

Expert Care in New York

IRB Approved

No-Cost Care

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