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]

[M15-954] A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS) - M15-954 (Verona)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200130

Enrollment

500

Registered

2020-09-25

Start date

2020-10-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Experimental: Arm 1: Venetoclax + Azacitidine (AZA) - Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (Days 1-7) of each 28 day cycle. - Interventions:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high). > Eastern Cooperative Oncology Group (ECOG) performance status of 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
- Overall survival (OS) [ Time Frame: Up To 5 Years ]	—

Countries

Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Netherlands, Poland, Puerto Rico, Russia, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactMedical information

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026