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Be Part of Research - Trial Details - Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
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Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Not Recruiting

Open to: ALL

Age: 18.0 - 130.0

Wolverhampton Cambridge Canterbury

Medical Conditions

Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2019 Jan 2027

Publications

"Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14."; "34534514"; "Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021."; "33796237"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Acalabrutinib,

Intervention Arm Group : Acalabrutinib, Venetoclax;Acalabrutinib, Venetoclax, Obinutuzumab;

Intervention Type : DRUG
Intervention Description : Venetoclax

Intervention Arm Group : Acalabrutinib, Venetoclax;Acalabrutinib, Venetoclax, Obinutuzumab;

Intervention Type : DRUG
Intervention Description : fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

Intervention Arm Group : Chemoimmunotherapy;

Intervention Type : DRUG
Intervention Description : Obinutuzumab

Intervention Arm Group : Acalabrutinib, Venetoclax, Obinutuzumab;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Wolverhampton
    WV10 OQP
  • Research Site
    Cambridge
    CB2 0QQ
  • Research Site
    Canterbury
    CT1 3NG


The study is sponsored by Acerta Pharma BV and is in collaboration with AstraZeneca.



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Read full details for Trial ID: NCT03836261
Last updated 24 December 2024

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