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Imfinzi NSCLC
Imfinzi NSCLC
Fachinformation
JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03836261

Studienbeginn:
Februar 2019

Letztes Update:
09.12.2020

Wirkstoff:
Acalabrutinib, Venetoclax, Chemoimmunotherapy, Obinutuzumab

Indikation (Clinical Trials):
Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell

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 212)

Research Site
50924 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
89081 Ulm
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
92708 Fountain Valley
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
32806 Orlando
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
C1426ANZ Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Research Site
C1181ACH Ciudad Autonoma Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Research Site
X5016KEH Córdoba
ArgentinaNoch nicht rekrutierend» Google-Maps
Research Site
90020-090 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
20230-130 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
22793-080 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01509-900 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
430022 Hankou,Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Research Site
69495 Pierre Benite
FranceNoch nicht rekrutierend» Google-Maps
Research Site
4818 CK Breda
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
197347 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
197341 St Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
21423 Jeddah
Saudi ArabiaNoch nicht rekrutierend» Google-Maps
Research Site
12713 Riyadh
Saudi ArabiaNoch nicht rekrutierend» Google-Maps
Research Site
14611 Riyadh
Saudi ArabiaNoch nicht rekrutierend» Google-Maps
Research Site
WV10 OQP Wolverhampton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy

and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously

untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3

arms through a block stratified randomization procedure.

The study includes screening (35 days), treatment (from randomization until study drug

discontinuation) and follow-up phase.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Men and women ≥18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)

- Active disease per IWCLL 2018 criteria that requires treatment.

- Participants must use highly effective birth control throughout the study.

Exclusion Criteria:

- Any prior CLL-specific therapies.

- Detected del(17p) or TP53 mutation.

- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's

transformation, prolymphocytic leukemia [PLL], or diffuse large B cell lymphoma

[DLBCL]), or central nervous system (CNS) involvement by leukemia.

- History of confirmed progressive multifocal leukoencephalopathy (PML).

- Received any investigational drug within 30 days before first dose of study drug.

- Major surgical procedure within 30 days before the first dose of study drug.

- Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart

failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4

cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are

allowed to enroll on study.

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or

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

absorption, symptomatic inflammatory bowel disease, or partial or complete bowel

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

- Received a live virus vaccination within 28 days of first dose of study drug.

- Known history of infection with human immunodeficiency virus (HIV).

- Serologic status reflecting active hepatitis B or C infection.

- History of known hypersensitivity or anaphylactic reactions to study drugs or

excipients.

- History of stroke or intracranial hemorrhage within 6 months before first dose of

study drug.

- Known bleeding disorders.

- Requires or receiving anticoagulation with warfarin or equivalent vitamin K

antagonists.

- Female participants must not be breastfeeding or pregnant.

- Concurrent participation in another therapeutic clinical trial.

Studien-Rationale

Primary outcome:

1. To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS (Time Frame - 6 years):
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria



Secondary outcome:

1. To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS (Time Frame - 6 years):
PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the IRC assessment and investigator assessment

2. To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared with FCR or BR (Arm C): PFS defined the same as above per investigator assessment. (Time Frame - 6 years):
PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the IRC assessment and investigator assessment

Studien-Arme

  • Experimental: Acalabrutinib, Venetoclax
    Acalabrutinib in combination with Venetoclax
  • Experimental: Acalabrutinib, Venetoclax, Obinutuzumab
    Acalabrutinib in combination with Venetoclax with or without Obinutuzumab
  • Active Comparator: Chemoimmunotherapy
    Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab

Geprüfte Regime

  • Acalabrutinib (Calquence (acalabrutinib)):
    Acalabrutinib,
  • Venetoclax (Venclyxto, Venclexta):
    Venetoclax
  • Chemoimmunotherapy:
    fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
  • Obinutuzumab (Gazyva, Gazyvaro):
    Obinutuzumab

Quelle: ClinicalTrials.gov


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