Morgantown, WVNCT06923488Now EnrollingIRB Ready

Myelodysplastic Syndromes Clinical Trial in Morgantown, WV

Access cutting-edge myelodysplastic syndromes treatment through this phase 1/2 clinical trial at a research site in Morgantown. Study-provided care at no cost to qualified participants.

Sponsored by West Virginia University

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Expert Care in Morgantown

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related myelodysplastic syndromes treatment provided free

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Check if you qualify for this myelodysplastic syndromes clinical trial in Morgantown, WV

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Why Participate?

  • No-Cost Study Care

  • Local to Morgantown

    Convenient for WV residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Morgantown site if eligible
  4. 4Begin participation

About This Myelodysplastic Syndromes Study in Morgantown

The goal of this interventional clinical trial is to evaluate the safety and tolerability of leflunomide in combination with decitabine as treatment for patients with relapsed or refractory myelodysplastic syndromes (R/R MDS). The main question this study aims to answer are to evaluate and estimate the maximum tolerated doses and/or biologically active doses of the combination of leflunomide-decitabine in participants. Decitabine will be administered at a dose of 20 mg/m2 by continuous intravenous infusion over one hour repeated daily for 5 days with repeating cycle every 4 weeks. Leflunomide is administered orally at 10 to 20 mg once daily (without a loading dose) for 14 to 21 days, as part of a 28-day treatment cycle in adult subjects with R/R MDS. After 12 cycles (study duration) responding patients can continue progression with the assigned doses.

Sponsor: West Virginia University

Who Can Participate

Inclusion Criteria

Patient has pathologically confirmed diagnosis of MDS
Patient has currently measurable disease meeting the following criteria:
Bone marrow biopsy with more than 5% blasts, AND
Absolute neutrophil count (ANC) less than 1,000/mcL, and/or platelet count less than 100,000/mcL and/or hemoglobin levels less than 10g/dL
Patient has received one prior treatment with a DNA methyltransferase inhibitor (DNMTi), also commonly called hypomethylating agent (HMA). Patients whose MDS has IDH1/IDH2 mutations should have received at least one available IDH1/IDH2 inhibitor
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Patient has the following required baseline laboratory data (eligibility can be based on local lab results):
Total serum bilirubin level less than or equal to 2 times ULN
Estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2
Patients who have undergone alloHSCT are eligible if they are more than 28 days post stem cell infusion, have no evidence of GVHD \> Grade 1, and are more than a week off all immunosuppressive therapy
If a female of childbearing potential, the patient has a negative serum or urine pregnancy test result within 7 days prior to the first dose of treatment. Women of non-childbearing potential are those who are postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy
If female of childbearing potential or a male patient, patient agrees to use an effective contraceptive method from the time of informed consent, during the course of the study, and for 3 months following the last dose of treatment
Patient understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution

Exclusion Criteria

Patients receiving any other investigational agents, or concurrent chemotherapy or immunotherapy
Patients with progression to acute myeloid leukemia
Patients with other malignancies requiring systemic chemotherapy, immunotherapy or targeted therapy in the last four weeks
Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms)
Patients with active or latent tuberculosis
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per Principal Investigator's judgment would limit compliance with study requirements
Females who are pregnant or breast feeding
Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

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 Morgantown?

Yes, this clinical trial (NCT06923488) has an active research site in Morgantown, WV 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.

Myelodysplastic Syndromes Treatment Options in Morgantown, WV

If you're searching for myelodysplastic syndromes treatment options in Morgantown, WV, this clinical trial (NCT06923488) 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 Morgantown research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced myelodysplastic syndromes 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 myelodysplastic syndromes clinical trials near you to find additional studies recruiting in your area.

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