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A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524308-31-00
Enrollment
40
Registered
2026-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Brief summary

Difference in Overall response rate (ORR) at course 2 defined as Complete response (CR) rate + Complete hematological response (CRh) + complete response with incomplete hematologic recovery (CRi) rate + Morphologic leukemia free state (MLFS) rate according ELN 2022 definition.

Detailed description

Proportion of patients experiencing adverse events (AE) and severe adverse events (SAE) graded according to NCI-CTCAE 5.0., Event-free survival defined as time from C1D1 to treatment failure, relapse or death from any reason. Treatment failure is defined as lack of response (no achievement of at least MLFS) after second treatment cycle., Overall survival defined as time from C1D1 to death from any reason.

Interventions

DRUGTAMBICICLIB 100 mg/10 mL
DRUGSolution for Injection
DRUGAZACITIDINE
DRUGTAMBICICLIB 100 mg/20 mL
DRUGVENETOCLAX

Sponsors

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in Overall response rate (ORR) at course 2 defined as Complete response (CR) rate + Complete hematological response (CRh) + complete response with incomplete hematologic recovery (CRi) rate + Morphologic leukemia free state (MLFS) rate according ELN 2022 definition.—

Secondary

MeasureTime frame
Proportion of patients experiencing adverse events (AE) and severe adverse events (SAE) graded according to NCI-CTCAE 5.0., Event-free survival defined as time from C1D1 to treatment failure, relapse or death from any reason. Treatment failure is defined as lack of response (no achievement of at least MLFS) after second treatment cycle., Overall survival defined as time from C1D1 to death from any reason.—

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026