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NCT04267081: VenEx

Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening

Completed Phase 2 Last updated 4 September 2024
What this trial tests

Phase 2 trial testing Venetoclax in Acute Myeloid Leukemia in 104 participants. Completed in 28 February 2024.

Timeline
12 February 2020
Primary endpoint
28 February 2024
28 February 2024

Quick facts

Lead sponsorHelsinki University Central Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment104
Start date12 February 2020
Primary completion28 February 2024
Estimated completion28 February 2024
Sites1 location across Finland

Drugs / interventions tested

Conditions studied

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 100, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi center two-stage, two-arm, open label phase II study of venetoclax in combination with azacytidine in acute myeloid leukemia patients selected for therapy with ex vivo venetoclax sensitivity screening. This study will characterize the usability of ex vivo drug sensitivity testing for patient selection for selecting the responsive patients for venetoclax therapy. The exploratory study will aim to find novel combinations for overcoming resistance as well as finding/validating biomarkers for both sensitivity and resistance.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. <i>Ex vivo</i> venetoclax sensitivity testing predicts treatment response in acute myeloid leukemia.
    Kuusanmäki H, Kytölä S, Vänttinen I, Ruokoranta T, et al · · 2023 · cited 46× · PMID 36519325 · DOI 10.3324/haematol.2022.281692
  2. Ex vivo venetoclax sensitivity predicts clinical response in acute myeloid leukemia in the prospective VenEx trial.
    Kytölä S, Vänttinen I, Ruokoranta T, Partanen A, et al · · 2025 · cited 24× · PMID 39357056 · DOI 10.1182/blood.2024024968
  3. Precision oncology using ex vivo technology: a step towards individualised cancer care?
    Williams ST, Wells G, Conroy S, Gagg H, et al · · 2022 · cited 14× · PMID 36184897 · DOI 10.1017/erm.2022.32
  4. Standardized assays to monitor drug sensitivity in hematologic cancers.
    Ayuda-Durán P, Hermansen JU, Giliberto M, Yin Y, et al · · 2023 · cited 12× · PMID 38040674 · DOI 10.1038/s41420-023-01722-5
  5. Targeting epigenetic mechanisms to overcome venetoclax resistance.
    Prado G, Kaestner CL, Licht JD, Bennett RL. · · 2021 · cited 12× · PMID 33945824 · DOI 10.1016/j.bbamcr.2021.119047
  6. Role of Biomarkers in the Management of Acute Myeloid Leukemia.
    Small S, Oh TS, Platanias LC. · · 2022 · cited 11× · PMID 36498870 · DOI 10.3390/ijms232314543
  7. Functional diagnostics using fresh uncultured lung tumor cells to guide personalized treatments.
    Talwelkar SS, Mäyränpää MI, Søraas L, Potdar S, et al · · 2021 · cited 8× · PMID 34467250 · DOI 10.1016/j.xcrm.2021.100373
  8. A Machine Learning-Based Strategy Predicts Selective and Synergistic Drug Combinations for Relapsed Acute Myeloid Leukemia.
    Chen Y, He L, Ianevski A, Nader K, et al · · 2025 · cited 6× · PMID 40354625 · DOI 10.1158/0008-5472.can-24-3840

Verify or expand the search:

Other trials of Venetoclax

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Helsinki University Central Hospital trials

Trials by the same sponsor.

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Data sources for this page

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