Prospective randomized multicenter phase III trial of decitabine and venetoclax administered in combination with all-trans retinoic acid or placebo in patients with acute myeloid leukemia who are ineligible for induction chemotherapy - DECIDER-2 trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507461-26-00

Acronym

P001516

Enrollment

256

Registered

2024-10-16

Start date

2022-09-22

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

Newly diagnosed acute myeloid leukemia (AML)

Brief summary

Overall survival (OS) time

Detailed description

Objective best response (CR, CRi, MLFS or PR), CR with negative MRD (CRMRD-), OS time with objective best response (CR, CRi, MLFS or PR), Quality of life (EORTC QLQ-C30) (especially fatigue) and FACIT Fatigue Scale

Interventions

DRUGVesanoid 10 mg Kapseln

DRUGP-Tabletten weiß 7 mm Lichtenstein

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) time	—

Secondary

Measure	Time frame
Objective best response (CR, CRi, MLFS or PR), CR with negative MRD (CRMRD-), OS time with objective best response (CR, CRi, MLFS or PR), Quality of life (EORTC QLQ-C30) (especially fatigue) and FACIT Fatigue Scale	—

Countries

Germany

Outcome results

None listed

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