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RecruitingLast updated:15 August 2023

VIALE-T: This phase III study is evaluating how effective a combined treatment of targeted therapy (venetoclax and azacitidine) is, compared to best supportive care, to improve outcomes in people with Acute Myeloid Leukaemia who have had an allogenic stem cell transplantA Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

Clinical summary

Summary

This study will have 2 parts: Part 1 (Dose Confirmation) and Part 2 (Randomisation). Part 1 seeks to determine the recommended Phase 3 dose (RP3D) of venetoclax in combination with azacitidine. In this part, participants will receiving various doses and dose regimens of venetoclax (orally) and azacitidine (via injection). Part 2 will further assess how safe and effective venetoclax with azacitidine is compared to Best Supportive Care. In Part 2, eligible participants will be randomly allocated to either Arm A or Arm B. In Part 2 Arm A, participants will receive venetoclax (orally) and azacitidine (via injection), in addition to Best Supportive Care. In Phase 2 Arm B, participants will receive Best Supportive Care as prescribed by their physician.

Age

People12+

Phase

III

Trial Acronym

VIALE-T

More information

Trial Identifiers

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Commercial Sponsor

AbbVie

Scientific Title

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

Eligibility

Inclusion

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

Exclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
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Clinical trials have complex eligibility criteria.

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