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NCT03552692

Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma

Terminated Phase 2 Last updated 12 December 2023
What this trial tests

Phase 2 trial testing Venetoclax in T-Cell Lymphoma Relapsed in 22 participants. Terminated before completion.

Timeline
25 September 2018
Primary endpoint
4 March 2020
17 February 2023

Quick facts

Lead sponsorFondazione Italiana Linfomi - ETS
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date25 September 2018
Primary completion4 March 2020
Estimated completion17 February 2023
Sites13 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Italiana Linfomi - ETS — full company profile →

Who can join

18 and older, any sex, with T-Cell Lymphoma Relapsed or T-Cell Lymphoma Refractory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The FIL\_VERT study is a phase II, open label, multicenter clinical trial. The primary of objective of the Study is to evaluate the efficacy of Venetoclax ABT-199/GDC-0199) in terms of overall response rate (ORR) in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH)

Publications & conference data

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

  1. Biomarker-driven management strategies for peripheral T cell lymphoma.
    Mulvey E, Ruan J. · · 2020 · cited 29× · PMID 32448357 · DOI 10.1186/s13045-020-00889-z
  2. Recent Advances in Diagnosis and Therapy of Angioimmunoblastic T Cell Lymphoma.
    Mohammed Saleh MF, Kotb A, Abdallah GEM, Muhsen IN, et al · · 2021 · cited 20× · PMID 34940095 · DOI 10.3390/curroncol28060456
  3. Genomics of Peripheral T-Cell Lymphoma and Its Implications for Personalized Medicine.
    Zhang Y, Lee D, Brimer T, Hussaini M, et al · · 2020 · cited 11× · PMID 32637355 · DOI 10.3389/fonc.2020.00898
  4. Updates in the Treatment of Peripheral T-Cell Lymphomas.
    Saleh K, Michot JM, Ribrag V. · · 2021 · cited 10× · PMID 34188559 · DOI 10.2147/jep.s262344
  5. Venetoclax Shows Low Therapeutic Activity in BCL2-Positive Relapsed/Refractory Peripheral T-Cell Lymphoma: A Phase 2 Study of the Fondazione Italiana Linfomi.
    Ballotta L, Zinzani PL, Pileri S, Bruna R, et al · · 2021 · cited 9× · PMID 34938664 · DOI 10.3389/fonc.2021.789891
  6. The Role of TRAIL Signaling in Cancer: Searching for New Therapeutic Strategies.
    Luo C, He S, Shi F, Zhou J, et al · · 2024 · cited 7× · PMID 39056714 · DOI 10.3390/biology13070521
  7. Precise diagnosis and targeted therapy of nodal T-follicular helper cell lymphoma (T-FHCL).
    Du J, Jin S, Zhang M, Fu X, et al · · 2023 · cited 3× · PMID 37188182 · DOI 10.3389/fonc.2023.1163190
  8. New Drug Development and Clinical Trial Design by Applying Genomic Information Management.
    Ko YK, Gim JA. · · 2022 · cited 2× · PMID 35893795 · DOI 10.3390/pharmaceutics14081539

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Other trials of Venetoclax

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Data sources for this page

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