OncoMatch/Clinical Trials/NCT05986240
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
Is NCT05986240 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05986240 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent disqualifies patients from enrollment.
What disease stage is eligible?
Stage RELAPSED or REFRACTORY or INTERMEDIATE IPSS-R or HIGH IPSS-R or VERY HIGH IPSS-R is required.
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