(Verona) 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 Syndromes (Higher-Risk MDS) | Aplastic Anemia & MDS International Foundation Return to top.

ClinicalTrials.gov Identifier:

NCT04401748

Contact Info

AbbVie Patient Recruitment Team

patientrecruitment@abbvie.com

Dates

Start: September 2020
End: February 2025

Official Title

(Verona) 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 Syndromes (Higher-Risk MDS)

Purpose

Myelodysplastic Syndromes (MDS) are a group of serious, rare bone marrow disorders where the body no longer makes enough healthy, normal blood cells in the bone marrow. MDS may progress to acute myeloid leukemia (AML). AML is a type of cancer that affects the blood and bone marrow.

Currently, there are very few treatment options for Higher-Risk MDS patients. Azacitidine is one of the approved treatments. The Verona study is a Phase 3, global, randomized, double-blind study to assess the safety and efficacy of venetoclax (an investigational drug) in combination with azacitidine, compared to placebo with azacitidine in subjects with newly diagnosed Higher-Risk MDS. This study will enroll approximately 500 patients from around the globe. Patients will be randomized 1:1 into either the venetoclax + azacitidine arm, or the placebo + azacitidine arm.

(Verona) 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 Syndromes (Higher-Risk MDS)

Clinical Trial: NCT04401748

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 3
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Adult male or female, at least 18 years old
  • Diagnosis of MDS according to the 2016 WHO classification with presence of <20% bone marrow blasts per bone marrow biopsy/aspirate at screening
  • Patients must have adequate liver functions as demonstrated by clinical laboratory assessments
  • No prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogeneic stem cell transplantation
  • 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 a plan for HSCT at the time of Study Day 1
Exclusion Criteria: 
  • Therapy-related MDS (tMDS)
  • 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 unclassified MDS/MPNHistory of any active malignancy within the past 2 years prior to screening, with the exception of:
    • Adequately treated carcinoma in situ of the uterine cervix;
    • Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
    • Asymptomatic prostate cancer without known metastatic disease, and with no requirement for therapy
  • Conditions that could interfere with drug absorption
  • Prior treatment with lenalidomide, anti-thymocyte globulin (ATG), and cyclosporin, as these are considered disease-modifying agents
  • Prior therapy with a BH3 mimetic
  • Females who are pregnant, breastfeeding, or considering becoming pregnant during the study
  • Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)

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Disclaimer:

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any clinical trial listed on this website. Pharmaceutical company sponsored content is highlighted only to give additional information about the trial. All trials are listed on https://clinicaltrials.gov/. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a clinical trial, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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