VIALE-T

A Study Evaluating Safety and Efficacy of an Active Drug in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Brief summary

The main objective of this study is to evaluate the efficacy of an active drug in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).

This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of an active drug in combination with azacitidine will be determined and during Part 2, the efficacy and safety of an active drug with azacitidine (Part 2 Arm A) will be compared with
BSC (Part 2 Arm B).

Interventional study

Status:
Recruiting
Conditions:
Acute Myeloid Leukemia (AML)
Cancer
Enrollment:
424 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-063
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

12 Years and older.

Inclusion Criteria:

- Participants must be at least 18 years old for Part 1 and, at least 12 years old for
Part 2.

- Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health
Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell
transplantation or have received allogeneic stem cell transplantation within the past
30 days.

- Blast percentage in bone marrow before transplant must be < 10%.

- Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must
be < 5% after transplant.

- Participant meet adequate renal, hepatic and hematologic criteria as described in the
protocol.

- Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50
and participants between 12 to 16 years old must have a Lansky Play Performance Scale
score > 40.

Exclusion Criteria:

- History of disease progression during prior treatment with venetoclax.

- History of any other malignancy within 2 years prior to study entry, except for:
Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of
breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the
skin; previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative
neoplasm (only allowed if it transformed to AML and AML should be the indication for
marrow transplantation).

- Participant has known infection with HIV or history of being positive for hepatitis B
virus (HBV) or hepatitis C virus (HCV) infection.

- Presence of clinical or laboratory symptoms/signs of extramedullary myeloid
malignancy.

All the cities where the clinical studies are located

Vancouver - V5Z 1M9

Ottawa - K1H 8L6

Toronto - M5G 2M9

Montreal - H1T 2M4

Montreal - H4A 3J1

British Columbia

Quebec

Saskatchewan