Nashville, TNNCT06399640Now EnrollingIRB Ready

Relapsed Myelodysplastic Syndrome Clinical Trial in Nashville, TN

Access cutting-edge relapsed myelodysplastic syndrome treatment through this clinical trial at a research site in Nashville. Study-provided care at no cost to qualified participants.

Sponsored by Vanderbilt-Ingram Cancer Center

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Expert Care in Nashville

Access relapsed myelodysplastic syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related relapsed myelodysplastic syndrome treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Nashville

    Convenient for TN 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 Nashville site if eligible
  4. 4Begin participation

About This Relapsed Myelodysplastic Syndrome Study in Nashville

This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping "tumor suppressing proteins" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and/or effective in treating patients with relapsed or refractory MDS or AML.

Sponsor: Vanderbilt-Ingram Cancer Center

Who Can Participate

Inclusion Criteria

\- Age \>/= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements. For Myelodysplastic Syndrome (MDS): Morphologically confirmed diagnosis of MDS with increased blasts (\>/= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles For Acute Myeloid Leukemia (AML): Morphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria that is relapsed or refractory following \>/= 1 line(s) of therapy.
WBC must be less than 25,000/ul prior to study start (hydroxyurea allowed).
A bone marrow aspirate must be performed, and tissue collected for entrance to the trial unless circulating blasts \>/= 5% in which case, peripheral blood can be used.
Eastern Cooperative Oncology Group Performance Status of 0 - 2.
Must have adequate hepatic and renal function as demonstrated by the following: ALT(SGPT) and/or AST (SGOT) \</= 3x upper limit of normal (ULN); Direct bilirubin \</= 1.5 x ULN; or Total bilirubin \</= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed); Calculated creatinine clearance \> 50 ml/min (per the Cockroft-Gault formula). \- Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications.

Exclusion Criteria

Anticancer therapy, including investigational agents \</= 2 weeks or \</= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).
Inadequate recovery from toxicity attributed to prior anti-cancer therapy to \</= Grade 1 (NCI CTCAE v5.0), excluding alopecia or fatigue.
Prior treatment with SINE compounds or other inhibitors of XPO1.
History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months.
Active acute or chronic GVHD requiring calcineurin inhibitors or steroid dosing \>/= 10mg/day or patients within 4 weeks of stopping calcineurin inhibitors for GVHD.
Radiation therapy or major surgery within 3 weeks.
Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis, even if parenteral, is acceptable.
Inability to swallow oral medications.
Active documented central nervous system leukemia.
Second active malignancy within past 2 years except for basal or squamous cell carcinoma of the skin, ductal carcinoma of breast in situ or cervical carcinoma in situ.
Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study
Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator.
Any condition not listed but deemed by the investigator to make the patient a poor candidate for clinical trial and/or treatment with investigational agents.

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 Nashville?

Yes, this clinical trial (NCT06399640) has an active research site in Nashville, TN 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.

Relapsed Myelodysplastic Syndrome Treatment Options in Nashville, TN

If you're searching for relapsed myelodysplastic syndrome treatment options in Nashville, TN, this clinical trial (NCT06399640) 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 Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsed myelodysplastic syndrome 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 relapsed myelodysplastic syndrome clinical trials near you to find additional studies recruiting in your area.

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