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NCT04253314: INNOVATE

A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

Completed Last updated 7 November 2024
What this trial tests

trial in Acute Myeloid Leukemia (AML) in 51 participants. Completed in 16 February 2023.

Timeline
13 March 2020
Primary endpoint
16 February 2023
16 February 2023

Quick facts

Lead sponsorAbbVie
StatusCompleted
Study typeOBSERVATIONAL
Enrollment51
Start date13 March 2020
Primary completion16 February 2023
Estimated completion16 February 2023
Sites10 locations across Russia

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Inducing apoptosis in acute myeloid leukemia; mechanisms and limitations.
    Koolivand Z, Bahreini F, Rayzan E, Rezaei N. · · 2025 · cited 3× · PMID 39811307 · DOI 10.1016/j.heliyon.2024.e41355

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

Other AbbVie trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04253314.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing