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Closed (no longer recruiting)Last updated: 9 January 2024

Verona: This phase III trial is evaluating the safety and effectiveness of a chemotherapy in combination with a cancer treatment known as Azacitidine (Vidaza) in patients with newly diagnosed higher-risk myelodysplastic syndromeA 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)

Clinical summary

Summary

Eligible patients will be randomised to receive either an oral placebo or oral venetoclax once daily (QD) (Days 1-14) in combination with (Azacitidine) AZA QD (Days 1-7) of each 28 day cycle.

Conditions

This trial is treating patients with Higher-Risk Myelodysplastic Syndrome.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

Verona

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific 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)

Eligibility

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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