Clinical Trial

Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML

Recruiting Phase 1
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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
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2023-08-01; most recent amendment 2025-11-06.
Status change: Not Yet Recruiting → Recruiting 2024-02-23
Status change: Recruiting → Not Yet Recruiting 2023-11-27
Status change: Not Yet Recruiting → Recruiting 2023-10-02
Trial Details
NCT Number NCT05986240
Lead Sponsor Montefiore Medical Center
Collaborators: M.D. Anderson Cancer Center, Flamingo Therapeutics NV
Conditions AML/MDS, Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 38 participants
Start Date 2024-05-08
Primary Completion 2027-06 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2025-11-10