112 Participants Needed

Venetoclax + Azacitidine for Leukemia

(VIALE-M Trial)

Recruiting at 311 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Research Team

AI

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with Acute Myeloid Leukemia (AML) who are in first remission after chemotherapy can join. They should have had a complete response within 120 days of the study drug or within 75 days from their last chemo. Participants need to be physically stable, with acceptable blood, kidney, and liver function tests and not have acute promyelocytic leukemia or AML affecting the brain.

Inclusion Criteria

I have been recently diagnosed with acute myeloid leukemia.
I achieved complete remission within 120 days of starting the study drug or had my last intensive chemotherapy no more than 75 days ago.
My AML is classified as intermediate or high risk.
See 3 more

Exclusion Criteria

My leukemia has affected my brain or spinal cord.
I have a history of acute promyelocytic leukemia.

Treatment Details

Interventions

  • Azacitidine
  • Venetoclax
Trial OverviewThe trial is testing oral Venetoclax tablets combined with Azacitidine (AZA), compared to just AZA alone as maintenance therapy for AML patients in remission. The study has two parts: one to confirm the dose of Venetoclax with AZA, and another to find the right dose when combined with CC-486.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Part 3 (Dose Finding): Safety ExpansionExperimental Treatment2 Interventions
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Group II: Part 3 (Dose Finding): Dose EscalationExperimental Treatment2 Interventions
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Group III: Part 1: Dose ConfirmationExperimental Treatment2 Interventions
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Vidaza for:
  • Acute myeloid leukemia
  • Chronic myelomonocytic leukemia
  • Myelodysplastic syndromes
🇺🇸
Approved in United States as Vidaza for:
  • Myelodysplastic syndromes
  • Chronic myelomonocytic leukemia
🇨🇦
Approved in Canada as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
🇯🇵
Approved in Japan as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Roche-Genentech

Industry Sponsor

Trials
27
Recruited
3,800+