NCT06399640 Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
| NCT ID | NCT06399640 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Condition | Relapsed Myelodysplastic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-08-14 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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: A
Frequently Asked Questions
Who can join the NCT06399640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Myelodysplastic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06399640 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06399640 currently recruiting?
Yes, NCT06399640 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vanderbilt-Ingram Cancer Center to inquire about joining.
Where is the NCT06399640 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06399640 clinical trial?
NCT06399640 is sponsored by Vanderbilt-Ingram Cancer Center. The trial plans to enroll 60 participants.