Status:
ACTIVE_NOT_RECRUITING
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cel...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT04401748
Start Date
September 10 2020
End Date
March 1 2026
Last Update
August 5 2025
Active Locations (220)
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1
Duplicate_Providence Medical Foundation /ID# 222633
Fullerton, California, United States, 92835
2
University of California, Los Angeles /ID# 221760
Los Angeles, California, United States, 90095
3
Torrance Memorial Physician Network Cancer Care /ID# 222702
Torrance, California, United States, 90505-5004
4
PIH Health Whittier Hospital /ID# 222647
Whittier, California, United States, 90602-1006