This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before. : A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation - Not available at this time
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
WHO International Clinical Trials Registry Platform - (2019) vom: 16. Dez. Zur Gesamtaufnahme - year:2019 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 29-05-2019, Last updated: 2022-11-24 |
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| ICTRP ID: |
EUCTR2018-002443-28-FR |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG004341139 |
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| 245 | 1 | 0 | |a This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before. |b A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation - Not available at this time |
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| 500 | |a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 29-05-2019, Last updated: 2022-11-24 | ||
| 650 | 4 | |a Medical Condition: Previously untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation MedDRA version: 20.0Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04] | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Phase: Phase 3 | |
| 650 | 4 | |a Recruitment Status: Authorised-recruitment may be ongoing or finished | |
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