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New treatment option for Relapsed Myelodysplastic Syndrome
Official title Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06399640
What this study is testing
What is Eltanexor?
Eltanexor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed myelodysplastic syndrome.
Also referred to as KPT-8602.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- 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...
- 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...
- 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) \ 50 ml/min (per the Cockroft-Gault...
You likely can't join if
- Anticancer therapy, including investigational agents \</= 2 weeks or \</= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of...
- 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...
- Radiation therapy or major surgery within 3 weeks.
See the full eligibility 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...
- 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) \ 50 ml/min (per the Cockroft-Gault formula). \- Willingness to abide by all study requirements, including...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.