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NCT05986240 · ClinicalTrials.gov registry record · Phase 1
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT05986240: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Montefiore Medical Center.
NCT05986240 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 38 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05986240, 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
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Funding Source: FDA OOPD
Primary Outcome
Overall Response Rate (ORR) will be used to assess clinical activity in AML and MDS participants. ORR will be measured as the percentage of participants demonstrating an objective overall response based upon a composite of remission related measures for AML and MDS participants as defined below. For AML participants, ORR will be defined as any confirmed Complete Remission (CR) + Complete Remission with Incomplete hematologic recovery (CRi) + Partial Remission (PR). or, AML = CR + CRi + PR For
Conditions Studied
Interventions
- DRUG Danvatirsen
- COMBINATION_PRODUCT Danvatirsen + Venetoclax
Study Locations (2)
New York
- Montefiore Medical Center - The Bronx
Texas
- M.D. Anderson Cancer Center, Department of Leukemia - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2024-05-08 |
| Est. Completion | 2030-03 |
| Phase | Phase 1 |
What NCT05986240 shows while recruiting
NCT05986240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Danvatirsen is the first listed.
NCT05986240 reports a single indexed study location in New York, Texas.
Frequently Asked Questions
What is clinical trial NCT05986240 about?
NCT05986240 is a clinical study titled "Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML". This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Funding Source: FDA OOPD
What is the current status of trial NCT05986240?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2024-05-08. Estimated completion is 2030-03.
What conditions does trial NCT05986240 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, AML/MDS.
What interventions are being tested in trial NCT05986240?
The interventions under investigation include: Danvatirsen (DRUG), Danvatirsen + Venetoclax (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05986240?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05986240 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05986240's enrollment target sits among peer trials
38 180th of 306 higher than 126 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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