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NCT06399640 · ClinicalTrials.gov registry record · Phase 1
Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06399640: Recruiting Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by Vanderbilt-Ingram Cancer Center.
NCT06399640 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06399640, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Adverse medical events will be tabulated and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Conditions Studied
Interventions
- DRUG Venetoclax
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Eltanexor
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 1 |
What NCT06399640 shows while recruiting
NCT06399640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT06399640 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06399640 about?
NCT06399640 is a clinical study titled "Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia". 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 prev...
What is the current status of trial NCT06399640?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-08-14. Estimated completion is 2027-10-01.
What conditions does trial NCT06399640 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome, Relapsed Myelodysplastic Syndrome.
What interventions are being tested in trial NCT06399640?
The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Eltanexor (DRUG).
Who is sponsoring clinical trial NCT06399640?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06399640 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06399640's enrollment target sits among peer trials
60 120th of 306 higher than 180 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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