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112 Participants Needed

Venetoclax + Azacitidine for Leukemia
(VIALE-M Trial)

Recruiting at 311 trial locations

Overseen ByABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Acute promyelocytic leukemia, CNS involvement

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Confirmation

Participants receive venetoclax once daily (QD) for up to 24 cycles and azacitidine (AZA) QD on Days 1-5 of each 28-day cycle for up to 6 cycles to determine the recommended Phase 3 dose (RPTD)

6 months

Dose Finding

Participants receive venetoclax QD and AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine the recommended Phase 3 dose (RPTD)

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Azacitidine
Venetoclax

Trial Overview The 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

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