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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05342584
The ClinicalTrials.gov registry entry for NCT05342584 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (15% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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