Safety And Efficacy Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Complete Remission and Overall Survival In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome (Verona) [M15-954]
- Conditions
- Myelodysplastic Syndrome (MDS)
- Registration Number
- JPRN-jRCT2031200130
- Lead Sponsor
- Okubo Sumiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.
- Participants must meet the following disease activity criteria:
> Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).
> Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
> Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.
- Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
- Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Complete Remission (CR) [ Time Frame: Up To 36 Months ]<br>- Overall survival (OS) [ Time Frame: Up To 5 Years ]
- Secondary Outcome Measures
Name Time Method