Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268574
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-01-05
Brief Title:
Safety and Efficacy of RVU120 for Treatment of RelapsedRefractory AML
Sponsor:
Ryvu Therapeutics SA
Organization:
Ryvu Therapeutics SA
Study Overview
Official Title:
A Multicenter Open-Label Clinical Trial of RVU120 in Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia with or Without NPM1 Mutation RIVER-52
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIVER-52
Brief Summary:
The goal of this study is to assess the safety tolerability anti-tumor activity efficacy pharmacokinetics PK and pharmacodynamics PD of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia AML or relapsed or progressing high-risk myelodysplastic syndrome HR-MDS and who have no alternative therapies available The study consists of two parts Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients
Detailed Description:
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 In Part 1 patients with AML or HR-MDS will be enrolled All patients will receive RVU120 until the patient meets eligibility for transplant until there is disease progression or if there are signs of intolerance A patient may withdraw from the study at any time at their own request or may be withdrawn at any time at the discretion of the Investigator Depending on the outcome of part 1 part 2 may include patients with HR-MDS and AML irrespective of NPM1 mutation status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None