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NCT05317403 · ClinicalTrials.gov registry record · Phase 1
Venetoclax to Augment Epigenetic Modification and Chemotherapy
A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05317403: Recruiting Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Medical College of Wisconsin.
NCT05317403 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 40 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05317403, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.
Primary Outcome
The primary endpoint, for dose escalation of venetoclax, is the occurrence of a dose-limiting toxicity (DLT) observed during the first course of therapy.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Vorinostat
- DRUG Azacitadine
Study Locations (1)
Wisconsin
- Children's Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-31 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What NCT05317403 shows while recruiting
NCT05317403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (30% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT05317403 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05317403 about?
NCT05317403 is a clinical study titled "Venetoclax to Augment Epigenetic Modification and Chemotherapy". The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.
What is the current status of trial NCT05317403?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-03-31. Estimated completion is 2027-01.
What conditions does trial NCT05317403 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory.
What interventions are being tested in trial NCT05317403?
The interventions under investigation include: Venetoclax (DRUG), Fludarabine (DRUG), Cytarabine (DRUG), Vorinostat (DRUG), Azacitadine (DRUG).
Who is sponsoring clinical trial NCT05317403?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05317403 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia, in Relapse
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05317403's enrollment target sits among peer trials
40 6th of 16 higher than 10 of 16 other Acute Myeloid Leukemia, in Relapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia, in Relapse 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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