OncoMatch/Clinical Trials/NCT05986240
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
Is NCT05986240 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Danvatirsen and Danvatirsen + Venetoclax for aml/mds.
Treatment: Danvatirsen · Danvatirsen + Venetoclax — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Disease stage
Required: Stage RELAPSED, REFRACTORY, INTERMEDIATE IPSS-R, HIGH IPSS-R, VERY HIGH IPSS-R (IPSS-R)
Excluded: Stage LOW OR VERY LOW RISK MDS BY IPSS-R
Subjects with relapsed/refractory AML...subjects with intermediated/high/very high IPSS-R MDS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: conventional therapy
Subjects with relapsed/refractory AML who are refractory or relapsed to all conventional therapy and do not have any FDA approved or standard therapeutic options
Must have received: hypomethylating agent (azacitidine, decitabine)
subjects with intermediated/high/very high IPSS-R MDS who are refractory or relapsed to at least 2 cycles of hypomethylating agent based therapy (azacitidine / decitabine based) OR patients with rapid progression of disease regardless of number of cycles of therapy
Cannot have received: investigational agent (danvatirsen)
Previous exposure to the investigational agent (danvatirsen)
Lab requirements
Kidney function
Serum creatinine clearance ≥ 45 mL/min/1.73 m2 either measured or calculated using standard Cockroft-Gault formula
Liver function
ALT (SGPT) and/or AST (SGOT) ≤ 3x ULN or ≤ 5x ULN if considered to be leukemia related; Direct bilirubin ≤ 1.5 x ULN or ≤ 3x ULN (in patients with known Gilberts syndrome or if considered to be leukemia related)
Must have adequate hepatic and renal function as follows: ALT (SGPT) and/or AST (SGOT) ≤ 3x ULN or ≤ 5x ULN if considered to be leukemia related; Direct bilirubin ≤ 1.5 x ULN or ≤ 3x ULN (in patients with known Gilberts syndrome or if considered to be leukemia related); Serum creatinine clearance ≥ 45 mL/min/1.73 m2 either measured or calculated using standard Cockroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Montefiore Medical Center · The Bronx, New York
- M.D. Anderson Cancer Center, Department of Leukemia · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify