Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

VIALE-T : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

12+Age Over 12

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

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 transplant.
 

This trial is treating patients with acute myeloid leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Commercial Sponsor

AbbVie

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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