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NCT06129734 · ClinicalTrials.gov registry record · Phase 1
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
A Phase 1 study of Acute Myeloid Leukemia and Myeloid Malignancy, sponsored by Benjamin Tomlinson.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06129734: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myeloid Malignancy, sponsored by Benjamin Tomlinson.
NCT06129734 is a Phase 1 study of Acute Myeloid Leukemia and Myeloid Malignancy that is actively recruiting participants, run by Benjamin Tomlinson. The registered enrollment target is 20 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06129734, a Phase 1 study of Acute Myeloid Leukemia and Myeloid Malignancy, is actively recruiting participants, sponsored by Benjamin Tomlinson.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.
Primary Outcome
The primary objective of this study will be to assess the safety of low dose decitabine/venetoclax in the post transplant setting. Safety will be defined in accordance with FDA guidance on development for new therapeutics in AML with the particular criteria to be considered as DLTs. The stopping criteria are described for the incidence of dose limiting toxicities that are at least possibly related to the study treatment. Using Bayesian toxicity monitoring with maximum DLT probability as 0.15,
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine
Study Locations (1)
Ohio
- University Hospitals Seidman Cancer, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06129734 shows while recruiting
NCT06129734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT06129734 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06129734 about?
NCT06129734 is a clinical study titled "Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant". The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main que...
What is the current status of trial NCT06129734?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-07-28. Estimated completion is 2027-07.
What conditions does trial NCT06129734 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myeloid Malignancy.
What interventions are being tested in trial NCT06129734?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT06129734?
This trial is sponsored by Benjamin Tomlinson, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06129734 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06129734's enrollment target sits among peer trials
20 246th of 306 higher than 50 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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