Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by John Glaspy

Description

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 cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Official Title

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)

Keywords

Myelodysplastic Syndrome (MDS), MDS, Myelodysplastic Syndrome, Venetoclax, Azacitidine, AZA, Venclexta, Preleukemia, Myelodysplastic Syndromes, Syndrome, Venetoclax + Azacitidine (AZA)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

Locations

  • University of California, Los Angeles /ID# 221760
    Los Angeles California 90095 United States
  • Torrance Memorial Physician Network Cancer Care /ID# 222702
    Torrance California 90505-5004 United States
  • PIH Health Whittier Hospital /ID# 222647
    Whittier California 90602-1006 United States

Lead Scientist at UCLA

  • John Glaspy
    Dr. John A. Glaspy holds the Simms/Mann Family Foundation Chair in Integrative Oncology.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT04401748
Phase
Phase 3 Myelodysplastic Syndrome Research Study
Study Type
Interventional
Participants
About 531 people participating
Last Updated