A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.

开始日期2011-01-01

申办/合作机构

medac Gesellschaft für klinische Spezialpräparate mbH

100 项与 Pegylated recombinant asparaginase(medac GmbH) 相关的临床结果

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100 项与 Pegylated recombinant asparaginase(medac GmbH) 相关的转化医学

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100 项与 Pegylated recombinant asparaginase(medac GmbH) 相关的专利（医药）

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项与 Pegylated recombinant asparaginase(medac GmbH) 相关的文献（医药）

2024-01-01·Pediatric blood & cancer

Lack of benefit from premedication for pegylated asparaginase during pediatric acute lymphoblastic leukemia/lymphoma therapy: A side‐by‐side comparison

Article

作者: Angus, Jonathan ; Leger, Kasey J ; Orgel, Etan ; Rushing, Teresa ; Menig, Sarah ; Dinh, Andrew ; Tucker, Sarah

Abstract:

Background:

Pegylated l‐asparaginase (PEG) is integral to treatment regimens for acute lymphoblastic leukemia (ALL) and lymphoma. Hypersensitivity reactions (HSRs) to PEG are common and can preclude continued administration. Data supporting recommendations for universal premedication (UPM) prior to PEG infusion to reduce incidence of HSRs are limited; UPM has become common practice.

Procedures:

Two free‐standing children's hospitals independently implemented UPM prior to PEG infusions in 2016 and 2019, respectively. In a side‐by‐side retrospective analysis, incidence and severity of HSRs were analyzed pre‐ and postimplementation of UPM in youth ≥1 years old treated with frontline PEG‐containing ALL regimens (2015–2018, 2016–2020). All HSRs were centrally reviewed within each institution to confirm and grade the HSR (Common Terminology Criteria for Adverse Events, v5). Planned analyses of subsets at potentially greater risk for HSRs included intensive PEG regimens (≥5 doses), adolescent and young adults (AYA), Hispanic/Latinx ethnicity, and obesity.

Results:

In 410 patients (by institution, n = 282 and n = 128), the overall incidence of Grade ≥ 3 HSRs was 20% (56 out of 282) and 18% (23 out of 128), respectively. No difference in incidence of Grade ≥ 3 HSRs in patients with versus without UPM was found at either institution (23 vs. 19%, p = .487 and 19 vs. 17%, p = .845). UPM also did not reduce the severity of HSRs, nor influence HSR risk within any patient subset.

Conclusions:

UPM prior to PEG infusion did not alter incidence or severity of HSRs at either institution. HSR remains a common complication of PEG therapy, impacting the patient experience. Alternative strategies to reduce HSRs are urgently required.

2023-09-19·Leukemia & lymphoma

Successful treatment of acute lymphoblastic leukemia (ALL) during pregnancy using a pediatric-based protocol incorporating pegylated asparaginase

Article

作者: Kumar, Poomahal ; Dalla-Pozza, Luciano ; Greenwood, Matthew ; Walsh, Colin A ; Kennedy, Debra ; Jeffrey, Anthony ; Presgrave, Peter ; Osborn, Michael ; Bradstock, Kenneth ; Sinn, John ; Trahair, Toby ; Anazodo, Antoinette

2023-05-01·British journal of haematology

Venous thromboembolism incidence associated with pegylated asparaginase (ASP) compared to the native L‐ASP: A retrospective analysis with an ASP‐based protocol in adult patients with acute lymphoblastic leukaemia

Article

作者: Liu, Xing ; Sibai, Hassan ; Atenafu, Eshetu G. ; Seki, Jack ; Shuh, Andre C. ; Chan, Steven ; Chen, RuiQi ; Yee, Karen ; Schimmer, Aaron D. ; Maze, Dawn ; Gupta, Vikas ; Minden, Mark D.

Summary:

Venous thromboembolism (VTE) is a well‐known complication in patients with acute lymphoblastic leukaemia (ALL) receiving asparaginase (ASP)‐based chemotherapy, including the ASP‐intensive Dana‐Farber Cancer Institute (DFCI) 91–01 protocol for adults. Since 2019, native L‐ASP is no longer available in Canada and was replaced by pegylated (PEG)‐ASP. To determine whether the incidence of VTE has changed since switching from L‐ASP to PEG‐ASP, we conducted a single‐centred retrospective cohort study. We included 245 adult patients with Philadelphia chromosome negative ALL between 2011 and 2021, with 175 from the L‐ASP group (2011–2019) and 70 from the PEG‐ASP group (2018–2021). During Induction, 10.29% (18/175) of patients who received L‐ASP developed VTE, whereas 28.57% (20/70) of patients who received PEG‐ASP developed VTE (p = 0.0035; odds ratio [OR] 3.35, 95% confidence interval [CI] 1.51–7.39), after adjusting for line type, gender, history of VTE, platelets at diagnosis. Similarly, during Intensification, 13.64% (18/132) of patients had VTE on L‐ASP while 34.37% (11/32) of patients on PEG‐ASP developed VTE (p = 0.0096; OR 3.96, 95% CI 1.57–9.96 with multivariable analysis). We found that PEG‐ASP is associated with a higher incidence of VTE compared to L‐ASP, both during Induction and Intensification, despite the administration of prophylactic anticoagulation. Further VTE mitigation strategies are needed in particular for adult patients with ALL receiving PEG‐ASP.

100 项与 Pegylated recombinant asparaginase(medac GmbH) 相关的药物交易

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