RIVER-52

RIVER-52

ClinicalTrials.gov ID NCT06268574 

Study population: women and man 18 Years and older

Study design: Patients entering the study will undergo a Screening Period of up to 21 days, a Treatment Period where they will take the drug every other day (7 times in 13 days) in cycles of 21 days, an End of Treatment period (lasting approximately 30 days after last dose), and a 1-year Follow-up Period where participants will be contacted every 3 months for progression and survival status.

Intervention/treatment: RVU120

Eligibility criteria: 

Inclusion Criteria 

  • Subjects must sign a written informed consent document and complete study related procedures
  • Patients must have a diagnosis of AML or HR-MDS (per 2022 WHO classification) with MDS confirmed as high risk with IPSS-R
  • Patients must have relapsed or refractory AML (per ELN 2022 criteria)
  • Patients must have relapsed or progressing HR-MDS (per IWG response criteria)
  • Patients must have failed first-line treatment and 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:

1. WBC < 30 x 10(9)/L on Day 1 prior to first dose of study drug

2. Platelet count > 10,000/mcL on Day 1 prior to first dose of study drug

3. Serum albumin ≥ 25 g/L (2.5 g/dL)

4. Normal coagulation (elevated international normalized ratio [INR], prothrombin time or activated partial thromboplastin time [APTT] <1.3 x the upper limit of normal [ULN] acceptable)

5. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)

6. Total bilirubin ≤ 3 x ULN

7. Creatinine clearance (Cockcroft & Gault formula) ≥ 30 mL/min

8. Exclusion Criteria:

  • Active central nervous system (CNS) leukemia.
  • Diagnosis of acute promyelocytic leukemia (APL), the M3 subtype of AML.
  • Previous treatment with CDK8 and/or CDK19-targeted therapy.
  • Major surgery within 28 days prior to first dose of study drug.
  • Hematopoietic stem cell transplant within 120 days prior to first dose of study drug.
  • Active, ≥Grade 2 acute graft versus host disease (GVHD), active moderate-to-severe chronic GVHD, or requirement for systemic immunosuppressive medications for GVHD
  • Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis).
  • Known seropositivity or history of active viral infection with human immunodeficiency virus (HIV).
  • Ongoing significant liver disease
  • Impairment of gastrointestinal function or gastrointestinal disease
  • Ongoing drug-induced pneumonitis.
  • Concurrent participation in another investigational clinical trial.
  • Taking any medications, herbal supplements, or other substances (including smoking) that may interfere with the metabolism of the study drug
  • Significant cardiac dysfunction defined as myocardial infarction within 12 months of first dose of study drug, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina or left ventricular ejection fraction (LVEF) <40% as per echocardiography or multiple gated acquisition (MUGA) scan.
  • History of ventricular arrhythmia, or QTc ≥470 ms (Bazett’s formula).
  • Prior history of malignancies other than AML, unless the participant has been free of the disease for 5 years or more prior to Screening
  • Pregnant or breast-feeding.

 

Participation criteria are verified by the investigator. Participation in the study is contingent upon meeting all inclusion criteria and meeting none of the exclusion criteria. The criteria provided may not be a complete list.  

 

Contact and locations:

Main Researcher Institution Address Phone Email
Dr n. med. Krzysztof Mądry MTZ Clinical Research powered by Pratia  Gładka 22
02-172 Warszawa		 +48669494678  [email protected]
Prof. Aleksandra Butrym  Specjalistyczny Szpital im. Dr A. Sokołowskiego w Wałbrzychu  Sokołowskiego 4
58-309 Wałbrzych		 +48746489736  [email protected] 
Dr n. med. Piotr Centkowski KO-MED Nova Sp. z o.o. Ośrodek Badań Klinicznych w Białej Podlaskiej ul. Terebelska 57-65
21-500 Biała Podlaska		 +48603314074, +48833067700

 

 [email protected], [email protected]
Dr n. med. Jarosław Dyko  Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii we Wrocławiu  ul. Grabiszyńska 105
53-439 Wrocław		 +48782999717  [email protected] 
Dr n. med. Witold Prejzner  Uniwersyteckie Centrum Kliniczne, Klinika Hematologii  
 i Transplantologii 		 ul. Smoluchowskiego 17
80-214 Gdańsk		 +48585844340  [email protected] 
Prof. Małgorzata Krawczyk-Kuliś  Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie  Wybrzeże Armii Krajowej 15
44-102 Gliwice		 +4832 278 8559  mailto:[email protected]
Dr n. med. Dominik Chraniuk  MICS Centrum Medyczne Toruń  Batorego 18-22
87-100 Toruń		 +48662062410    [email protected]