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Anti-sense oligonucleotide

Danvatirsen + Venetoclax for MDS & AML

Phase 1

Recruiting

Led By Aditi Shastri, MBBS

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 21 days after initiation of study treatment to within 14 days following treatment discontinuation; up to 14 weeks total

Awards & highlights

Study Summary

This trial studies a new drug to treat advanced blood cancers like MDS and AML.

Who is the study for?

Adults diagnosed with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), who have tried conventional therapies without success, can join this trial. They must be in relatively good health otherwise, with a decent performance status and proper liver and kidney function. Pregnant women, those with certain other cancers or severe heart issues, active infections, CNS leukemia, or drug abuse cannot participate.Check my eligibility

What is being tested?

The study is testing Danvatirsen alone first and then in combination with Venetoclax to see how safe and effective they are for treating MDS/AML that hasn't responded to standard treatments. It's an early-phase trial which means it's one of the first times these drugs are being tested together in humans.See study design

What are the potential side effects?

Potential side effects aren't specified here but generally could include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, liver or kidney issues due to medication toxicity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 21 days after initiation of study treatment to within 14 days following treatment discontinuation; up to 14 weeks total

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 21 days after initiation of study treatment to within 14 days following treatment discontinuation; up to 14 weeks total

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 21 days after initiation of study treatment to within 14 days following treatment discontinuation; up to 14 weeks total for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response to Therapy as determined by Overall Response Rate

Secondary outcome measures

30 Day All-cause mortality

60 Day All-cause Mortality

Duration of Response

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Danvatirsen MonotherapyExperimental Treatment1 Intervention

Patients will be enrolled in cohorts of 3 for the Danvatirsen dose escalation substudy. Based on the DLT of the first cohort of participants, subsequent cohorts will either be administered doses at the next higher dose level, de-escalated to the next lower dose level, or remain the same. Dose escalation discontinuations and MTD will be determined as described in the 'Detailed Study Description.' The total duration of 1 cycle is approximately 4 weeks (28 days). Proposed dose levels and treatment schedule are as follows: Dose Level 1 (DL1): Danvatirsen Day 1 - Day 28 (1mg/kg loading dose on Cycle 1/Day 1 (C1D1), Cycle 1/Day 3 (C1D3); and Cycle 1/Day 5 (C1D5) followed by weekly 1mg/kg infusion for 3 weeks) Dose Level 2 (DL2): Danvatirsen Day 1 - Day 28 (2mg/kg loading dose on C1D1, C1D3, and C1D5 followed by weekly 2mg/kg infusion for 3 weeks) Dose Level 3 (DL3): Danvatirsen Day 1 - Day 28 (3mg/kg loading dose on C1D1, C1D3, and C1D5 followed by weekly 3mg/kg infusion for 3 weeks)

Group II: Danvatirsen + Venetoclax Combination TherapyExperimental Treatment1 Intervention

Patients will be enrolled in cohorts of 3 for the Danvatirsen + Venetoclax dose escalation substudy. Dose escalation administration will be as described in the Danvatirsen monotherapy substudy arm and dose escalation discontinuations and MTD will be determined as described in the 'Detailed Study Description.' Up to 2 dose levels of Danvatirsen will be evaluated based on data from the Danvatirsen monotherapy arm. Dose 1 will be one level lower than the dose with expected target activity. Venetoclax: 400 mg (or equivalent) administered as fixed dose daily (except for specific dose modifications described in the protocol) orally for 28 days per cycle. To mitigate risk of tumor lysis syndrome, during Cycle 1 Venetoclax will be dose escalated daily to the goal dose of 400mg daily (100mg on Day 1, 200mg on Day 2 and 400mg on Day 3, and onwards, or adjusted dose ramp-up per Venetoclax label if on concomitant azoles). The three cycles are approximately 28 days each in duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Danvatirsen

2019

Completed Phase 2

~90

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Flamingo Therapeutics NVIndustry Sponsor

1 Previous Clinical Trials

81 Total Patients Enrolled

Montefiore Medical CenterLead Sponsor

444 Previous Clinical Trials

582,536 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,974 Previous Clinical Trials

1,789,452 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research currently accept new participants?

"As indicated on clinicaltrials.gov, this ongoing trial is presently recruiting participants. It was published at the beginning of October (10/1/2023) and updated recently ( 10/2/2023)."

Answered by AI

Has the joint Danvatirsen + Venetoclax Combination Therapy been validated by governmental regulations?

"The safety of Danvatirsen + Venetoclax Combination Therapy was evaluated as a 1 on our scale from 1 to 3, due to the scarcity of data for Phase 1 trials supporting its efficacy and protection."

Answered by AI

How many participants are engaging in this clinical experiment?

"Correct. The information on clinicaltrials.gov affirms that this study, which was initially posted October 1st 2023, is in the process of recruiting subjects. A total of 24 individuals must be sourced from 2 distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05986240.