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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
AML diagnosis according to the 2016 World Health Organisation (WHO) classification (Arber et al. 2016) with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care; or Myelodysplastic Syndrome (MDS) diagnosis according to the 2016 WHO classification (Arber et al. 2016) with high-risk disease per the Revised International Prognostic Scoring System (IPSS-R >4.5) and with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care
Age ≥18 years
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 belowSelect...
I have AML or MDS with no treatment options left.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreOther outcome measures
AML surface markers
Genetic profile changes in AML blasts
Phosphorylated protein levels in AML blasts
+1 moreTrial 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.
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Who is running the clinical trial?
Ryvu Therapeutics SALead Sponsor
4 Previous Clinical Trials
353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for 5 years, except for AML or MDS.I have stopped all cancer treatments before joining this study.I currently have or recently tested positive for COVID-19.I have recovered from side effects of my previous cancer treatments.I am currently experiencing symptoms of acute graft versus host disease.I have not had major surgery in the last 28 days.I am not taking medication known to affect heart rhythm.You are expected to live for at least 12 more weeks.My leukemia has spread to my brain or spinal cord.I am not pregnant and agree to use effective birth control during and 6 months after the study.I have AML or MDS with no treatment options left.I have been treated with CDK8-targeted therapy before.I do not have any current infections or inflammation.You or someone in your family has had a serious heart rhythm problem, or your heart's QT interval is longer than normal.I have serious heart problems or chest pain that is not well managed.I am currently experiencing lung inflammation due to medication.I am a man and will use contraception during the study and for 6 months after, and won't donate sperm or blood.I am 18 years old or older.I have a digestive system condition.I have a serious liver condition.I can take care of myself and am up and about more than half of my waking hours.I am not taking any substances that strongly affect my liver enzymes or heart rhythm.I had a stem cell transplant less than 120 days ago.My heart is functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: RVU120(SEL120)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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