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NCT02462538

Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL

Terminated Phase 1, PHASE2 Last updated 3 March 2022
What this trial tests

Phase 1, PHASE2 trial testing Brentuximab vedotin in ALK+ Anaplastic Large Cell Lymphoma in 3 participants. Terminated before completion.

Timeline
3 November 2015
Primary endpoint
3 November 2021
3 November 2021

Quick facts

Lead sponsorArbeitsgemeinschaft medikamentoese Tumortherapie
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date3 November 2015
Primary completion3 November 2021
Estimated completion3 November 2021
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie — full company profile →

Who can join

18 and older, any sex, with ALK+ Anaplastic Large Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label pilot study of combining BV in a licensed indication with imatinib in patients with ALCL. It is intended as a "window of opportunity" trial in which the study drugs will be given as an initial substitute for conventional chemotherapy with the intention to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell transplantation, if eligible.

Publications & conference data

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

  1. Anaplastic large cell lymphoma: pathology, genetics, and clinical aspects.
    Tsuyama N, Sakamoto K, Sakata S, Dobashi A, et al · · 2017 · cited 79× · PMID 29279550 · DOI 10.3960/jslrt.17023
  2. Treatment Options for Paediatric Anaplastic Large Cell Lymphoma (ALCL): Current Standard and beyond.
    Prokoph N, Larose H, Lim MS, Burke GAA, et al · · 2018 · cited 58× · PMID 29601554 · DOI 10.3390/cancers10040099
  3. Brentuximab vedotin for treatment of non-Hodgkin lymphomas: A systematic review.
    Berger GK, McBride A, Lawson S, Royball K, et al · · 2017 · cited 58× · PMID 28010897 · DOI 10.1016/j.critrevonc.2016.11.009
  4. Unlocking the NF-κB Conundrum: Embracing Complexity to Achieve Specificity.
    Begalli F, Bennett J, Capece D, Verzella D, et al · · 2017 · cited 51× · PMID 28829404 · DOI 10.3390/biomedicines5030050
  5. The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
    Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
  6. Adult systemic anaplastic large-cell lymphoma: recommendations for diagnosis and management.
    Bennani-Baiti N, Ansell S, Feldman AL. · · 2016 · cited 15× · PMID 26581318 · DOI 10.1586/17474086.2016.1122514
  7. Anaplastic lymphoma kinase-special immunity and immunotherapy.
    Guo Y, Guo H, Zhang Y, Cui J. · · 2022 · cited 4× · PMID 35958559 · DOI 10.3389/fimmu.2022.908894

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