Trial studying safety and effects for Acute Myeloid Leukemia
Official title Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
ClinicalTrials.gov ID: NCT06191263
What this study is testing
What is RVU120?
RVU120 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as SEL120.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have a diagnosis of AML (per 2022 WHO classification)
- Patients must have relapsed or refractory AML (per ELN 2022 criteria)
- Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent
- Patients must have no alternative therapeutic options likely to produce clinical benefit
- Patients must have ECOG performance status of 0 to 2
You likely can't join if
- APL (acute promyelocytic leukemia), the M3 subtype of AML
- Active CNS (central nervous system) leukemia
- Previous treatment with CDK8 and/or CDK19-targeted therapy
- Major surgery within 28 days prior to the first dose of study drug
- Hematopoietic stem cell transplant within 120 days prior to the first dose of study drug
- Currently pregnant or breast-feeding. Females of child bearing potential must have a negative serum pregnancy test within 72 hours prior to the first...
See the full eligibility criteria
- Patients must have a diagnosis of AML (per 2022 WHO classification)
- Patients must have relapsed or refractory AML (per ELN 2022 criteria)
- Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent
- Patients must have no alternative therapeutic options likely to produce clinical benefit
- Patients must have ECOG performance status of 0 to 2
- Patients must have adequate end organ function defined as:
- WBC \< 25 x 10(9)/L on Day 1 prior to first dose of study drug
- Platelet count \> 10,000/mcL on Day 1 prior to first dose of study drug
- AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)
- Total bilirubin ≤ 3 x ULN
- Creatinine clearance (Cockcroft \& Gault formula) ≥ 50 mL/min
- LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography
- people must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures
- APL (acute promyelocytic leukemia), the M3 subtype of AML
- Active CNS (central nervous system) leukemia
- Previous treatment with CDK8 and/or CDK19-targeted therapy
- Major surgery within 28 days prior to the first dose of study drug
- Hematopoietic stem cell transplant within 120 days prior to the first dose of study drug
- Currently pregnant or breast-feeding. Females of child bearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug
- Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes but is not limited to:
- Active, Grade ≥2 acute GVHD (graft versus host disease) or requirement for systemic immunosuppressive medication for GVHD
- Evidence of ongoing or uncontrolled systemic bacterial, fungal or viral infection and acute inflammatory conditions (including pancreatitis)
- Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis, or chronic persistent hepatitis B and/or hepatitis C
- Ongoing drug-induced pneumonitis
- Significant cardiac dysfunction, defined as myocardial infarction within 12 months prior to the first dose of study drug, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled dysrhythmias...
- History of ventricular arrhythmia or QTc ≥ 470 ms (Bazett's formula)
- Prior history of malignancies other than AML, unless disease-free for 5 years or more or prior basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, carcinoma in situ of cervix, breast or...
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 and/or venetoclax
- Taking any medications, herbal supplements, or other substances (including smoking( that are known to be strong inhibitors or moderate/strong inducers or sensitive substrates of CYP1A2
- Taking any medications, over-the-counter medications, foods or herbal supplements that are known to be strong or moderate inhibitors of CYP3A4 or P-gp (P-glycoprotein)
- Known allergy or hypersensitivity to any component of RVU120 or venetoclax formulations
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
- Le Mans, France
- Lille, France
- Marseille, France
- Nice, France
- Nîmes, France
- Paris, France
- Rouen, France
- Meldola, Forlì-Cesena, Italy
- Ancona, Italy
- Bologna, Italy
- Brescia, Italy
- Lecce, Italy
- Ravenna, Italy
- Roma, Italy
- Rozzano, Italy
- Turin, Italy
- Warsaw, Mazowieckie Województwo, Poland
- Biała Podlaska, Poland
- Gdansk, Poland
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France; Le Mans, France; Lille, France; Marseille, France; Nice, France; Nîmes, France and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.