VIALE-M

A Safety and Efficacy Study of Oral Active Drug Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival

Brief summary

The main objective of this study is to evaluate safety and efficacy of an active drug in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of an active drug in as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive an active drug and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.

Interventional study

Status:
Recruiting
Conditions:
Acute Myeloid Leukemia (AML)
Enrollment:
482 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-708
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of newly diagnosed acute myeloid leukemia (AML).

- Participant meets the following disease activity criteria:

- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have
confirmed complete remission (CR) or complete remission with incomplete blood
count recovery (CRi) following completion of intensive induction and
consolidation chemotherapies.

- Achieved first CR + CRi within 120days of first dose of study drug or be no more
than 75 days since last dose of intensive conventional chemotherapies.

- AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer
Network (NCCN) 2016 criteria.

- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

- Participant must have adequate hematologic, renal, and liver function laboratory
values as described in the protocol.

Exclusion Criteria:

- History of acute promyelocytic leukemia (APL).

- History of active central nervous system involvement with acute myeloid leukemia
(AML).

All the cities where the clinical studies are located

Calgary - T2N 4N2
Edmonton - T6G 2B7
Halifax - B3H 2Y9
Hamilton - L8V 1C3
London - N6A 5W9
Ottawa - K1H 8L6
Toronto - M5G 2M9
Montreal - H4A 3J1