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Imfinzi NSCLC
Imfinzi NSCLC

JOURNAL ONKOLOGIE – STUDIE

ESCALADE A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB Subtype DLBCL (ACE-LY-312)

Rekrutierend

NCT-Nummer:
NCT04529772

Studienbeginn:
Oktober 2020

Letztes Update:
13.01.2021

Wirkstoff:
Acalabrutinib, Placebo, Prednisone, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin

Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Acerta Pharma BV

Collaborator:
AstraZeneca

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen

Studienlocations (3 von 203)

Research Site
96049 Bamberg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
10967 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
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22081 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
66421 Homburg
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
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73557 Mutlangen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
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48149 Münster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
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24534 Neumünster
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
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85711 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
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80218 Denver
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06360 Norwich
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33901 Fort Myers
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33705-1449 Saint Petersburg
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32308-5304 Tallahassee
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33401 West Palm Beach
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50309 Des Moines
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67214 Wichita
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40207 Louisville
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49503 Grand Rapids
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55802-2227 Duluth
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64132 Kansas City
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63129 Saint Louis
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59102 Billings
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12206 Albany
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10028 New York
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97213 Portland
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15212 Pittsburgh
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37404 Chattanooga
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78234-4504 Fort Sam Houston
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79410 Lubbock
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24153 Salem
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2050 Camperdown
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2010 Darlinghurst
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3084 Heidelberg
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4101 South Brisbane
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81520-060 Curitiba
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88034-000 Florianopolis
BrazilNoch nicht rekrutierend» Google-Maps
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90035-003 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
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90110-270 Porto Alegre
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14051-140 Ribeirão Preto
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22793-080 Rio de Janeiro
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01509-900 Sao Paulo
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04029-000 Sao Paulo
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05652-900 Sao Paulo
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13083-878 Sao Paulo
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01323-001 São Paulo
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100191 Haidian District
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200032 Xuhui District
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500 05 Hradec Kralove
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708 52 Ostrava - Poruba
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14033 Caen Cedex 9
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69495 Pierre Benite
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35033 Rennes Cedex 9
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8410101 Beer Sheba
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4941492 Petah Tikva
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812-8582 Fukuoka-shi
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920-0293 Kahoku-gun
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791-0280 Matsuyama-shi
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460-0001 Nagoya-shi
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464-8681 Nagoya-shi
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951-8520 Niigata-shi
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700-8558 Okayama-shi
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49201 Busan
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10408 Goyang-si
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54907 Jeonjusi Deokjingu
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49241 Seo-Gu
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03080 Seoul
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03722 Seoul
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06591 Seoul
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5505 Seoul
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6351 Seoul
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16499 Suwon-si
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4454-509 Matosinhos
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4434-502 Vila Nova de Gaia
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454087 Chelyabinsk
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420029 Kazan
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115478 Moscow
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125284 Moscow
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185019 Petrozavodsk
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197022 St. Petersburg
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Research Site
08908 L'Hospitalet de Llobregat
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Research Site
29000 Khmelnytskyi
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Studien-Informationen

Detailed Description:

Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and

safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and

prednisone (R-CHOP) as compared with placebo plus R-CHOP in subjects ≤65 years of age with

previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell

(ABC) and unclassified).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Men and women, age ≥18 and ≤65 years

- Pathologically confirmed DLBCL, sufficient diagnostic material should be available to

forward to a central laboratory for gene expression profiling and pathology review.

- No prior treatment for DLBCL

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- International Prognostic Index (IPI) score of 2 to 5

- Disease Stage II to IV by the Ann Arbor Classification

- Adequate organ and marrow function

- Agreement to use highly effective forms of contraception during the study and 12

months after the last dose of rituximab

Exclusion Criteria:

- Evidence of severe or uncontrolled systemic diseases

- Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)

- History of stroke or intracranial haemorrhage in preceding 6 months.

- Known CNS lymphoma or leptomeningeal disease

- Known primary mediastinal lymphoma

- Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements

- Prior history of indolent lymphoma

- History of or ongoing confirmed progressive multifocal leukoencephalopathy

- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,

congestive heart failure, or myocardial infarction within 6 months of first dose of

study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart

Association Functional Classification

- Malabsorption syndrome, disease significantly affecting gastrointestinal function,

resection of the stomach, extensive small bowel resection that is likely to affect

absorption, symptomatic inflammatory bowel disease, partial or complete bowel

obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.

- Uncontrolled active systemic fungal, bacterial, viral, or other infection

- Prior anthracycline use ≥150 mg/m2

- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.

- Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole,

lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving

proton pump inhibitors who switch to short-acting H2-receptor antagonists or antacids

are eligible for enrolment into this study.

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B (Time Frame - 60 months)



Secondary outcome:

1. Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B (Time Frame - 60 months)

2. Overall survival in Arm A compared to Arm B (Time Frame - 60 months)

3. Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification at the end of study treatment (Time Frame - Up to 32 weeks)

Studien-Arme

  • Experimental: acalabrutinib + R-CHOP
    Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
  • Placebo Comparator: placebo + R-CHOP
    Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Geprüfte Regime

  • acalabrutinib:
    Investigational Product
  • placebo:
    Placebo comparator
  • Prednisone:
    Investigational Product
  • Rituximab:
    Investigational Product
  • Cyclophosphamide:
    Investigational Product
  • Vincristine:
    Investigational Product
  • Doxorubicin:
    Investigational Product

Quelle: ClinicalTrials.gov


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