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RecruitingPhase 1NCT05986240

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

A Phase I Study Investigating the Safety & Efficacy of Danvatirsen as Monotherapy Followed by Combination With Venetoclax in Patients With Relapsed/Refractory MDS & AML

Sponsor

Montefiore Medical Center

Enrollment

38 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesAML/MDS

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called danvatirsen — first alone, then combined with another drug called venetoclax — in people with relapsed or treatment-resistant myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), two serious blood cancers. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with AML or MDS that has come back or has not responded to prior treatment - You are willing and able to meet all study requirements **You may NOT be eligible if...** - You have not previously received treatment for AML or MDS - You are under 18 years of age - You are unable to meet study visit requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDanvatirsen

Danvatirsen (AZD9150) is a selective, high-affinity, antisense oligonucleotide inhibitor of signal transducer and activator of transcription 3 (or STAT3).

COMBINATION_PRODUCTDanvatirsen + Venetoclax

Danvatirsen (AZD9150) is a selective, high-affinity, antisense oligonucleotide inhibitor of signal transducer and activator of transcription 3 (or STAT3). Venetoclax: Commercially available. Venetoclax is a potent, selective small molecule inhibitor of BCL-2, an anti-apoptotic protein found on some types of cancer cells.

Locations(2)

Montefiore Medical Center

The Bronx, New York, United States

M.D. Anderson Cancer Center, Department of Leukemia

Houston, Texas, United States

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NCT05986240

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