Estudio primario

No clasificado

Año 2018
Revista Journal of Clinical Oncology
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Background: Bruton tyrosine kinase (BTK) is a clinically validated target in WM. Acalabrutinib is a highly selective, potent, covalent BTK inhibitor that we evaluated in a Phase 2 study of pts with treatment-naive (TN) or relapsed/refractory (R/R) WM. Methods: Pts with TN or R/R WM received 100 mg acalabrutinib BID (or 200 mg QD [n=6], later switched to 100 mg BID) in 28-day cycles until progressive disease (PD) or intolerance. The primary endpoint was investigator-assessed overall response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and PK. Results: One hundred six pts (14 TN and 92 R/R) were treated; median age was 69 y (range 39-90); 94% had ECOG PS ≤1; median serum IgM was 3615 mg/dL (range 291-9740). R/R pts had a median of 2 prior therapies (range 1-7). At a 25-mo median follow-up, 7 (50%) TN and 70 (76%) R/R pts remain on treatment. Discontinuations were primarily due to PD (TN 0 pts; R/R 9 pts), adverse events (AEs; TN 3; R/R 3), and investigator decision (TN 2; R/R 4). BTK occupancy and PK parameters were consistent with previous acalabrutinib studies. Efficacy outcomes are listed in the Table. Common AEs (any grade) were headache (39%), diarrhea (31%), contusion (29%), and dizziness (25%). Common Gr 3/4 AEs were neutropenia (16%), pneumonia (7%), anemia, increased ALT, and hyponatremia (each 5%). Atrial fibrillation occurred in 3 pts (1 Gr 3). Bleeding events occurred in 57% of pts (commonly contusion [29%] and epistaxis [13%]); 4 events were Gr 3/4: epistaxis, hematuria, dysfunctional uterine bleeding, and retinal hemorrhage. There were 5 Gr 5 events: pneumonia, glioblastoma multiforme, esophageal carcinoma, myocardial ischemia, and intracranial hematoma. Conclusions: Acalabrutinib is a highly effective treatment for WM with durable responses and limited toxicity.

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Estudio primario

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Año 2017
Registro de estudios clinicaltrials.gov
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This is a single center, open-label, phase II study of venetoclax (ABT-199) added to ibrutinib or acalabrutinib in patients with high-risk CLL who have received at least 12 months of ibrutinib or acalabrutinib monotherapy.

The study will estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable CLL after receiving ibrutinib or acalabrutinib for at least 12 months and who have high risk CLL.

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Año 2022
Registro de estudios clinicaltrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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This study evaluates the effectiveness of acalabrutinib treatment in patients with chronic lymphocytic leukemia (CLL) deemed at high risk for Richter\'s Transformation (RT). This is a single arm study. Enrolled patients will initiate therapy with acalabrutinib and will dose continuously. While on study, subjects will be monitored monthly for the first 3 months, then every three months thereafter until disease progression, discontinuation due to toxicity, death, or study completion.

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Año 2023
Registro de estudios clinicaltrials.gov

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This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma.

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Año 2025
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This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

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Estudio primario

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Año 2020
Autores University of Miami
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The purpose of this study is to test a combination treatment of acalabrutunib when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) to evaluate if it will be able to improve durable responses and cure some patients.

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Año 2021
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This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL).

The names of the study drugs involved in this study are:

* Copanlisib
* Ibrutinib
* Acalabrutinib

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Año 2023
Autores AstraZeneca
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Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the adults in the Western world, with an annual incidence of approximately 5 cases per 100,000 inhabitants in Italy.

Acalabrutinib (CalquenceTM), a selective second-generation Bruton Tyrosine Kinase (BTK) inhibitor developed by AstraZeneca, has been assessed for the treatment of CLL in three phase III clinical trials, ELEVATE-TN (treatment-naïve CLL), ASCEND and ELEVATE R/R (relapsed and refractory CLL). These pivotal randomized clinical trials established the efficacy and safety of acalabrutinib in patients with CLL and based on these data CalquenceTM received EMA approval in November 2020 for the treatment of CLL in adult patients and received AIFA (Agenzia Italiana del Farmaco) reimbursement as monotherapy in December 2021. However, further data are still required to evaluate the use of acalabrutinib in the real-life conditions of post-marketing authorization.

The primary aim of ARISE study is to evaluate the time to treatment discontinuation and reasons for discontinuation for acalabrutinib in a real world setting of patients with CLL. This study will provide the first real-world data on the use of acalabrutinib in the treatment of CLL in Italy.

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Estudio primario

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Año 2020
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This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.

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Estudio primario

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Año 2020
Registro de estudios clinicaltrials.gov
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This phase II trial studies how well acalabrutinib works in treating patients with mantle cell lymphoma that cannot tolerate ibrutinib. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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