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PHASE II STUDY OF AZACITIDINE IN COMBINATION WITH LOW DOSE INTENSITY VENETOCLAX IN PATIENTS WITH ACUTE MYELOID LEUKEMIA WITH INTEGRATION OF EXPLORATIVE MULTI-OMICS AND EX VIVO DRUG SCREENING DATA

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510415-19-00
Enrollment
147
Registered
2024-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-05

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

ORR (including CR/CRh/CRi/MLFS rate, composite CR/CRh/CRi rate, PR rate).

Detailed description

Overall survival (OS), duration of response (DOR), progression free survival (PFS)., Frequency and severity of adverse events (hematologic toxicities-AE grade 3+4, febrile neutropenia, days until neutrophil recovery ≥ 0.5 x 10E9/l and platelet recovery ≥ 50 x 10E9/l, severe AE grade 3+4).

Interventions

DRUGAZACITIDINE
DRUGVENETOCLAX

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR (including CR/CRh/CRi/MLFS rate, composite CR/CRh/CRi rate, PR rate).

Secondary

MeasureTime frame
Overall survival (OS), duration of response (DOR), progression free survival (PFS)., Frequency and severity of adverse events (hematologic toxicities-AE grade 3+4, febrile neutropenia, days until neutrophil recovery ≥ 0.5 x 10E9/l and platelet recovery ≥ 50 x 10E9/l, severe AE grade 3+4).

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026