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CDK8/19 Inhibitor

RVU120 for Leukemia and Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by Ryvu Therapeutics SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have been off anti-cancer treatment prior to study
Patients must have recovered from the toxic effects of previous treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test a new drug for leukemia and myelodysplastic syndrome to see if it is safe and effective.

Who is the study for?
Adults over 18 with Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome who have tried all standard treatments without success. They must be in good general health, not pregnant, willing to use contraception, and not have certain heart conditions or other serious medical issues.Check my eligibility
What is being tested?
The trial is testing RVU120 (SEL120), a new drug aimed at inhibiting specific enzymes involved in cancer cell growth. It's for patients whose leukemia or syndrome hasn't responded to other treatments, assessing the best dose for future studies and its safety and effectiveness.See study design
What are the potential side effects?
Possible side effects of RVU120 are not detailed here but may include typical reactions related to cancer drugs such as fatigue, nausea, blood count changes, liver function alterations, and potential heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stopped all cancer treatments before joining this study.
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I have recovered from side effects of my previous cancer treatments.
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I am not pregnant and agree to use effective birth control during and 6 months after the study.
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I have AML or MDS with no treatment options left.
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I am a man and will use contraception during the study and for 6 months after, and won't donate sperm or blood.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My heart is functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (Safety and Tolerability)
Recommended dose (RD)
Secondary outcome measures
Anti-leukemic activity
The Area Under the Curve (AUC)
The Maximum Observed Concentration (C[max])
+2 more
Other outcome measures
AML surface markers
Genetic profile changes in AML blasts
Phosphorylated protein levels in AML blasts
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RVU120(SEL120)Experimental Treatment1 Intervention
The first part of the study consists of dose-escalation cohorts where patients will receive ascending doses of RVU120(SEL120) to determine the recommended dose (RD) for further clinical development. The second part of the study is an enrichment cohort where additional 6 to 20 patients will be treated with RVU120(SEL120) to support the evaluation of the RD.

Find a Location

Who is running the clinical trial?

Ryvu Therapeutics SALead Sponsor
4 Previous Clinical Trials
353 Total Patients Enrolled

Media Library

RVU120(SEL120) (CDK8/19 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04021368 — Phase 1
Acute Myeloid Leukemia Research Study Groups: RVU120(SEL120)
Acute Myeloid Leukemia Clinical Trial 2023: RVU120(SEL120) Highlights & Side Effects. Trial Name: NCT04021368 — Phase 1
RVU120(SEL120) (CDK8/19 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04021368 — Phase 1

Frequently Asked Questions

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

Is this research endeavor presently seeking participants?

"As per clinicaltrials.gov, this medical trial is currently accepting participants. It was initially published on September 4th 2019 and the details were last amended November 5th 2021."

Answered by AI

How many participants are being accepted into this experiment?

"This clinical trial necessitates 54 applicants with the relevant eligibility conditions. Patients can enrol in this medical research at multiple locations, including MD Anderson Cancer Center (Houston, Texas) and Sylvester Comprehensive Cancer Centre & University of Miami Hospital and Clinics (Miami, Florida)."

Answered by AI

What major goals is this clinical trial attempting to achieve?

"This clinical trial will monitor its primary outcome, the Recommended Dose (RD), for up to 18 months. Secondary objectives include the Terminal Half-life (t[1/2]), Area Under the Curve (AUC) and Maximum Observed Concentration (C[max]) of SEL120 which are all pharmacokinetic profiles assessing drug efficacy."

Answered by AI

Has RVU120(SEL120) been sanctioned by the Food and Drug Administration?

"RVU120(SEL120) has only been tested on a limited basis, so it was given an initial safety score of 1."

Answered by AI

How widely available is this trial among Canadian medical facilities?

"At the moment, this research project is enrolling patients from 5 different sites located in Houston, Miami and Saint Louis along with two other cities. To reduce travel-related stressors associated with participating in the trial, it's best to select a centre that's closest geographically."

Answered by AI
~14 spots leftby Dec 2024