Oncaspar liquid (pegaspargase) / Servier - LARVOL DELTA

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma (clinicaltrials.gov) - P2/3 | N=790 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial completion date: Mar 2028 ➔ Sep 2028

Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • BCL2

ECOG-ACRIN E1910: Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=488 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • CD4 • CDKN2A • ETV6 • IGH • PBX1 • RUNX1 • TCF3

Universal Premedication Does Not Impact Transition to Short-Acting Asparaginase or Incidence of Hypersensitivity to Pegylated Asparaginase: A Single-Institution Experience. (PubMed, J Pediatr Hematol Oncol) - "Children's Hospital Colorado implemented universal pegaspargase premedication in May 2020 and a retrospective analysis was conducted to compare the rates of transition to Erwinia products and hypersensitivity reactions between the preimplementation and postimplementation cohorts. In this large single-institution experience, universal premedication did not impact rates of Erwinia transition or hypersensitivity reactions."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Oncology

Dynamic change in Epstein-Barr virus DNA predicts prognosis in early stage natural killer/T-cell lymphoma with pegaspargase-based treatment: long-term follow-up and biomarker analysis from the NHL-004 multicenter randomized study. (PubMed, Haematologica) - "The multi-center randomized phase 3 NHL-004 study compared etoposide, dexamethasone and pegaspargase (ESA) versus methotrexate, etoposide, dexamethasone and pegaspargase (MESA) regimen, combined with sandwiched radiotherapy, in newly diagnosed early-stage nasal natural killer/T-cell lymphoma (NKTCL). With low toxicity, non-intravenous and outpatient design, ESA with sandwiched radiotherapy achieved long-term durable response in patients with newly diagnosed early-stage NKTCL. Dynamic monitoring of plasma EBV DNA provided clinical rationale in future mechanism-based therapy of NKTCL."

Biomarker • Journal • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Comparison of pegaspargase with concurrent radiation vs. P-GEMOX with sequential radiation in early-stage NK/T-cell lymphoma. (PubMed, Oncol Res) - "This study aimed to evaluate and compare the clinical outcomes and adverse events (AEs) associated with two treatment regimens for early-stage NKTCL: pegaspargase with concurrent radiation therapy (P+CCRT) and pegaspargase, gemcitabine, and oxaliplatin (P-GEMOX) with sequential radiation therapy (SERT). Additionally, P+CCRT offers the benefit of a more streamlined treatment regimen with a shorter cycle. Given these encouraging results, further cohort studies are needed to validate these results."

Clinical • Journal • Hematological Disorders • Hematological Malignancies • Hepatology • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children with Hematoplastic Disease (clinicaltrials.gov) - P4 | N=1500 | Recruiting | Sponsor: Wei Zhao | Unknown status ➔ Recruiting | Trial completion date: Dec 2021 ➔ Dec 2026 | Trial primary completion date: Dec 2021 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

Phase 2 multicenter study of pegaspargase in Japanese patients with previously untreated acute lymphoblastic leukemia. (PubMed, Int J Hematol) - "Plasma asparaginase activity reached ≥ 0.1 IU/ml 5 min after the first dose of lyophilized pegaspargase and was maintained for 14 days in all patients with evaluable samples. The results of this study show that lyophilized pegaspargase represents an effective and well-tolerated first-line treatment option in Japanese patients with ALL."

Clinical • Journal • P2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

UKALL14: Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P=N/A | N=0 | Completed | Sponsor: University College, London | Active, not recruiting ➔ Completed | N=1033 ➔ 0 | Trial completion date: Dec 2025 ➔ Feb 2025

Enrollment change • Trial completion • Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Mucositis • Oncology • Stomatitis • ABL1 • BCR • MYC

Efficacy and safety of PEMD regimen in newly diagnosed early-stage non-upper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma (PubMed, Zhonghua Xue Ye Xue Za Zhi) - "Objective: To evaluate the efficacy and safety of the pegaspargase, etoposide, methotrexate, and dexamethasone (PEMD) regimen in patients with early-stage nonupper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma (ENKTL) . The main adverse effect was anemia in 31 patients (81.6%) . The PEMD regimen was safe and effective for patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL."

Journal • Retrospective data • Hematological Disorders • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL) (clinicaltrials.gov) - P3 | N=207 | Recruiting | Sponsor: Sun Yat-sen University | Trial completion date: Jun 2025 ➔ Dec 2028 | Trial primary completion date: Apr 2025 ➔ Dec 2028

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Recognition, prevention, and management of adverse events associated with asparaginase / pegaspargase treatment of acute lymphoblastic leukemia in adults: consensus of an expert panel. (PubMed, Haematologica) - "The clinical statements were grouped into 5 distinct categories: 1) hepatotoxicity; 2) hypersensitivity reactions; 3) thromboembolic and coagulopathy complications; 4) pancreatitis and metabolic complications; and 5) dosing. The intent of these statements is to provide health care providers with information that will help them mitigate, monitor for, and manage the most common and/or unique ASNase-induced AEs in adult ALL patients, allowing these patients to receive more or all the planned ASNase doses and thereby improve outcomes."

Adverse events • Journal • Acute Lymphocytic Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Leukemia • Lymphoma • Oncology • Pancreatitis • Pediatrics

Cerebral Venous Thrombosis Secondary to Pegaspargase (Peg-Asparaginase): A Case Report and Literature Review (AAN 2025) - "To the author's knowledge, six cases of CVST and pegaspargase were published and our current report. The mean and median age were 29.5 (SD: 12.6) and 34 (range: 13–50 years), respectively. Five reports occurred in females."

Case report • Clinical • Review • Acute Lymphocytic Leukemia • Cardiovascular • CNS Disorders • Epilepsy • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Thrombosis

Higher Rates of Hypersensitivity Reactions to Calaspargase Compared With Pegaspargase: A Single Center Retrospective Review. (PubMed, Pediatr Blood Cancer) - "The current administration of Cal-PEG in large cooperative group trials will allow for a postmarketing exploration of the true risk of HSR and associated patient-specific risk factors."

Journal • Retrospective data • Acute Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Oncology • Pediatrics

Clinical Characteristics and Prognosis Analysis of Patients with Extranasal NK/T-Cell Lymphoma: A Multicenter Retrospective Study of Huaihai Lymphoma Working Group (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "The clinicopathological characteristics of extranasal NKTCL patients with different sites of involvement are vary, and effective individualized treatment need to be further explored."

Journal • Retrospective data • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • NCAM1

AALL15P1: Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (clinicaltrials.gov) - P2 | N=78 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Dec 2024

Trial completion • Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A

Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma (clinicaltrials.gov) - P2 | N=49 | Recruiting | Sponsor: Peking Union Medical College Hospital

New P2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A 12-Step Desensitization Protocol for Calaspargase Pegol-mknl. (PubMed, J Pediatr Pharmacol Ther) - "Asparaginase Erwinia chrysanthemi (recombinant)-rywn (recombinant Erwinia) is an alternative for those with HSRs to pegaspargase. Here, we describe an 11-year-old boy with relapsed ALL who developed HSRs to both pegaspargase and recombinant Erwinia. This is the report of a novel desensitization protocol for calaspargase pegol-mknl (calaspargase) with no adverse events and adequate serum asparaginase activity."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Oncology

Metabolic parameter of baseline 18 F-FDG PET/CT with PINK models improve the prediction of treatment outcome in extranodal NK/T-cell lymphoma treated with P-GEMOX chemotherapy. (PubMed, Ann Hematol) - "The aim of this study was to investigate the prognostic value of baseline PET/CT parameters alone and combined with clinical features in Extranodal Natural killer/T-cell lymphoma (ENKTL) patients treated with P-GEMOX regimen (pegaspargase, gemcitabine and oxaliplatin). A total of 97 patients were retrospectively evaluated. SUVmean was an independent prognostic factor in patients with ENKTL treated with P-GEMOX chemotherapy. Adding SUVmean to the PINK or PINKE model could improve the predictive value and further distinguish patients with poor outcomes."

Journal • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov) - P2 | N=171 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jan 2025 ➔ Apr 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2L1 • KMT2A • MCL1

Superficial Dorsal Vein Thrombosis of the Penis and Pulmonary Embolism in a 15-year-old Boy: A Case Report. (PubMed, Clin Pract Cases Emerg Med) - "To our knowledge, this is the first case report of an adolescent with superficial dorsal vein thrombosis of the penis and a coexisting PE. Doppler ultrasound can provide a prompt assessment of penile induration and differentiate venous thrombosis from other causes."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Mood Disorders • Oncology • Pain • Pulmonary Embolism • Respiratory Diseases

Desensitization to calaspargase pegol appears to be less successful than pegaspargase. (PubMed, Blood Adv) - No abstract available

Journal

Pharmacovigilance analysis of drug-induced hypofibrinogenemia using the FDA Adverse Event Reporting System. (PubMed, Int J Clin Pharm) - "This analysis of FAERS data identified 52 drugs associated with hypofibrinogenemia, most (88.5%) of which do not mention this risk in their prescribing information. These findings demonstrate the need for the monitoring of blood fibrinogen and may serve as a reference for the explore of the characteristics and underlying mechanism of drug-induced hypofibrinogenemia in the real world."

Adverse events • Journal

Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Hepatology • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CRLF2 • PNPLA3 • SOD2

A prospective, multicenter, single-arm clinical study evaluating the efficacy and safety of Golidocitinib combined with P-Gemox in patients with newly diagnosed stage III/IV or non-upper respiratory/digestive extranodal NK/T cell lymphoma (ChiCTR) - P1 | N=20 | Recruiting | Sponsor: The first affiliated hospital Zhejiang University school of medicine; The first affiliated hospital Zhejiang University school of medicine

New P1 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma