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NCT05342584 · ClinicalTrials.gov registry record · Phase 1
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
- 1
- Study location
NCT05342584: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Montefiore Medical Center.
NCT05342584 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 99 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05342584, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.
Primary Outcome
The number and percentage of patients with SAEs and AEs, including AEs leading to dose modifications or discontinuations, will be summarized.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Venetoclax Oral Tablet
Study Locations (1)
New York
- Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM) - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT05342584 shows while recruiting
NCT05342584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (15% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cytarabine is the first listed.
NCT05342584 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05342584 about?
NCT05342584 is a clinical study titled "Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS". This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax ...
What is the current status of trial NCT05342584?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2022-05-25. Estimated completion is 2028-12.
What conditions does trial NCT05342584 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT05342584?
The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Venetoclax Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05342584?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05342584 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05342584's enrollment target sits among peer trials
99 85th of 306 higher than 222 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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