Oncaspar liquid (pegaspargase) / Servier - LARVOL DELTA

Tislelizumab plus P-GemOx-14 and Radiotherapy for Early-Stage High-Risk Extranodal NK/T-Cell Lymphoma: A Multicenter, Single-Arm, Phase 2 Trial (ASTRO 2026) - "Patients received induction chemo-immunotherapy (CIT) with tislelizumab-P-GemOx-14 (tislelizumab 200 mg intravenously on day 1, pegaspargase 3000 IU intramuscularly on day 2, gemcitabine 1000 mg/m2 intravenously on day 2, and oxaliplatin 85 mg/m2 intravenously on day 2) every 14 days for three cycles, followed by involved-site radiotherapy (50 Gy in 25 fractions) with concurrent tislelizumab (200 mg intravenously on day 1, 15, 22 during radiotherapy). The addition of tislelizumab to induction P-GemOx-14 and radiotherapy showed activity and safety in patients with early-stage high-risk ENKTCL."

Clinical • P2 data • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. (ASCO 2024) - "The CLAMP regimen is effective and safe and seems to reduce the incidence of CNS involvement and HLH. The CLAMP regimen may be a promising option in the treatment of NKTCL lymphoma."

Clinical • P2 data • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Oncology • Rare Diseases • T Cell Non-Hodgkin Lymphoma

Sintilimab Plus P-Gemox (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly-Diagnosed Advanced, Extranodal Natural Killer/T Cell Lymphoma, Nasal Type: A Multicenter, Phase 2 Cohort of the Open-Label Spirit Study (ASH 2022) - P2 | "Combination of sintilimab plus P-GEMOX Regimen yielded promising clinical activity with a manageable safety profile, supporting immunochemotherapy as a new first-line treatment option for pts with advanced ENKTL. Treatment and follow-up are currently ongoing and further studies have been initiated to explore biomarkers to better predict response and long-term survival."

Clinical • IO biomarker • P2 data • Anemia • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma. (PubMed, J Clin Oncol) - "Patients with T-LL had significantly improved EFS and OS with bortezomib on the AALL1231 backbone. Systemic therapy intensification allowed elimination of CRT in more than 90% of patients with T-ALL without excess relapse."

Journal • P3 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Concurrent Chronic Active Epstein-Barr Virus Disease and Extranodal NK/T-Cell Lymphoma as an Isolated Orbital Recurrence After Autologous Stem Cell Transplantation: A Case Report (SOHO 2026) - "She received reduced-dose dexamethasone, cisplatin, gemcitabine, pegaspargase (DDGP) with partial metabolic response after 3 cycles. Our case demonstrates that CAEBV-associated clonal T-cell disease and ENKTL can coexist in the same anatomic site, highlighting the importance of integrated clinical, morphologic, immunophenotypic, and molecular evaluation. ASCT: autologous stem cell transplantation; BEAM: carmustine, etoposide, cytarabine, and melphalan; CD: cluster of differentiation; CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone; DDX3X: DEAD-box helicase 3 Xlinked; EBER: EBV-encoded small RNA; EBV: Epstein-Barr virus; KMT2D: lysine methyltransferase 2D; MRI: magnetic resonance imaging; NK: natural killer; PCR: polymerase chain reaction; TCR: T-cell receptor; TIA-1: T-cell intracellular antigen-1."

Case report • Clinical • IO biomarker • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD2 • CD4 • CD5 • CD7 • CD8 • DDX3X • KMT2D • NCAM1

Risk-Adjusted Therapies Yield Equivalent Outcomes for Adolescents and Young Adults (AYAs) Treated for Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) on Children's Oncology Group (COG) Studies AALL0434 and AALL1231 (ASH 2023) - "On AALL0434, participants were randomized to receive escalating dose methotrexate (CMTX) without leucovorin rescue + pegaspargase or high dose MTX (HDMTX) + leucovorin rescue. Intermediate and high-risk patients were randomized to receive or not receive six 5-day courses of nelarabine (Nel)...Key differences between AALL0434 and AALL1231 ABFM backbones included the use of prednisone in induction in AALL0434 versus dexamethasone in AALL1231, and cranial radiation therapy in the majority of AALL0434 participants versus only in patients with central nervous system involvement in AALL1231...Despite small numbers, CMTX holds a survival advantage for AYA T-ALL patients, with no survival disadvantage seen among AYA T-ALL patients who received Nel. Bortezomib does not offer significant benefit for AYA T-ALL patients."

Clinical • Acute Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Respiratory Diseases • Septic Shock • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

First-line sintilimab with pegaspargase, gemcitabine, and oxaliplatin in advanced extranodal natural killer/T cell lymphoma (SPIRIT): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Haematol) - P2 | "Combination of sintilimab with P-GEMOX seems to be an active and safe first-line regimen for patients with advanced ENKTL."

Journal • Metastases • P2 data • Dyslipidemia • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Hypertriglyceridemia • Lymphoma • Neutropenia • Oncology • T Cell Non-Hodgkin Lymphoma

Incorporating Immunotherapy into Upfront ALL Therapy (SOHO 2024) - "Treatment of B-lineage acute lymphoblastic leukemia (B-ALL) has seen notable improvement in outcomes in the past few years with the advent of the use of pediatric-intensive regimens for adolescents and young adults, the use of measurable residual disease (MRD) for risk assessment, and the introduction of potent immunotherapeutic agents, including blinatumomab (Blin), inotuzumab ozogamicin (InO), and chimeric-antigen receptor T-cell (CAR-T) therapy...8 The United States intergroup E1910 trial treated Ph-neg B-ALL adults (age range of 30–70 years) with 2 months of induction chemotherapy followed by an intensification cycle of high-dose methotrexate and pegaspargase for central nervous system (CNS) prophylaxis...The estimated EFS and OS rates were 95% and 95%, respectively.13 The U.S. intergroup is currently conducting a phase III randomized trial of dasatinib or ponatinib (investigator’s choice) with HyperCVAD or blinatumomab in patients aged 18–70 years with newly..."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22 • IKZF1

Enteric NK/T Cell Lymphoma-induced Recurrent Perforation in the Intestine: A Case Report. (PubMed, Ann Ital Chir) - "Primary intestinal ENKTL is a rare and highly aggressive subtype of non-Hodgkin lymphoma, whose non-specific clinical and imaging manifestations pose major challenges for early diagnosis, which may lead to delayed treatment and unfavorable prognosis. This disease should be included in the core differential diagnosis for young patients, especially Asian populations, presenting with unexplained gastrointestinal perforation. Repeated deep tissue biopsy, EBER detection combined with comprehensive imaging evaluation are essential for early definitive diagnosis, and timely surgical intervention combined with standardized systemic chemotherapy can effectively improve the clinical outcomes of affected patients."

Journal • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • T Cell Non-Hodgkin Lymphoma • CD2 • NCAM1

Impact of Additional Intensive L-Asparaginase Therapy during Consolidation Phase for High-Risk Acute Lymphoblastic Leukemia: Results of a Randomized Controlled Trial in the AIEOP-BFM ALL 2009 Protocol (ASH 2022) - P3 | "The AIEOP-BFM ALL 2009 protocol included a randomized study for patients with high-risk (HR) features, to investigate if an intensive and continuous exposure to pegylated L-Asparaginase (Peg-L-ASP), given on top of BFM consolidation phase IB, could decrease the levels of MRD and to influence long term outcome...Treatment consisted of a 7-day prephase with prednisone and 1 intrathecal dose of methotrexate (ITMTX), an induction protocol IA with prednisone or dexamethasone, vincristine, daunomycin, Peg-L-ASP (2 doses), ITMTX and, only in PPR T-ALL cyclophosphamide. Patients eligible were randomized to receive or not 4 weekly doses of Peg-L-ASP (2500 IU/sqm x 4) on top of consolidation phase IB, which included 6-MP, cyclophosphamide, cytosine arabinoside and ITMTX...Importantly, in both analyses, by ITT and by treatment given, there is no evidence of benefit on reduction of relapses by the additional therapy with Peg-L-ASP in phase IB. These findings indicate that an..."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • AFF1 • KMT2A

Consolidation Therapy with Blinatumomab Improves Overall Survival in Newly Diagnosed Adult Patients with B-Lineage Acute Lymphoblastic Leukemia in Measurable Residual Disease Negative Remission: Results from the ECOG-ACRIN E1910 Randomized Phase III National Cooperative Clinical Trials Network Trial (ASH 2022) - " Patients (pts) between the ages of 30 and 70 with newly diagnosed BCR::ABL1 negative B-lineage ALL were enrolled and initially received 2.5 months of combination induction chemo utilizing a BFM-like regimen adapted from the E2993/UKALLXII clinical trial with extended remission induction, addition of pegaspargase for patients <55 years of age and addition of rituximab for CD20 positive patients (figure 1)... The addition of blin to consolidation chemo resulted in a significantly better overall survival in pts with newly diagnosed B-lineage ALL who were MRD negative after intensification chemo. No significant safety concerns were noted. The addition of blin to consolidation chem in adult pts aged 30-70 years represents a new standard of care for BCR::ABL1 negative ALL pts."

Clinical • Late-breaking abstract • P3 data • Residual disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • ABL1 • CD20 • POMP

Addition of Inotuzumab to a Pediatric Inspired Chemotherapy Regimen in Young Adult Patients with B-Cell Acute Lymphoblastic Leukemia: Findings from the Alliance A041501 Phase 3 Randomized Trial (ASH 2024) - P3 | "Eligible pts received the CALGB 10403 regimen modified to omit extended induction, include dexamethasone as opposed to prednisone as steroid backbone, cap the pegaspargase dose to 3750 units, and adding rituximab for pts with CD20 expression (> 20%). INO may still be efficacious if late toxicity can be mitigated. A pilot study is planned that will decrease INO dose, add 2 cycles of blinatumomab and strict infectious prophylaxis guidelines."

Clinical • P3 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Septic Shock • ABL1 • CD20 • CD22

Efficacy and Toxicity of Fixed Dose Versus Reduced/PK-Adjusted Dose Pegaspargase in Pediatric Patients with Newly Diagnosed Acute Lymphoblastic Leukemia: Results of DFCI ALL Consortium Protocol 16-001 (ASH 2024) - "Conclusions We demonstrate that a reduced/PK-adjusted dose approach for treatment with SS-PEG is feasible in newly diagnosed ALL pts, and preliminary outcome results suggest no decrement in EFS (longer follow-up needed). Despite marked decrease in SAA with reduced/PK-adjusted dosing, rates of non-allergic asparaginase-related toxicities were not reduced compared with standard dosing, suggesting that further investigation of alternative strategies to minimize treatment-limiting toxicities and improve tolerability is warranted."

Clinical • Acute Lymphocytic Leukemia • Cardiovascular • Dyslipidemia • Hematological Malignancies • Hepatology • Hypertriglyceridemia • Immunology • Leukemia • Oncology • Pancreatitis • Pediatrics

Preliminary results of an open-label, single-arm phase 2/3 trial (SPARK-ALL) of calaspargase pegol in adults with newly diagnosed Philadelphia chromosome–negative acute lymphoblastic leukemia. (ASCO 2026) - P2/3 | "In patients (pts) <21 years, calaspargase pegol (Cal-PEG) provides more sustained asparagine depletion than pegaspargase. Cal-PEG has a safety profile consistent with asparaginase class toxicity and, as part of multidrug chemotherapy regimen, provides sustained asparagine depletion in newly diagnosed Ph− ALL pts aged ≥22 years. In light of the observed high-grade TRAEs, future studies will evaluate different Cal-PEG doses for this pt population."

Clinical • P2/3 data • Acute Lymphocytic Leukemia • Dyslipidemia • Hematological Disorders • Hematological Malignancies • Hypertriglyceridemia • Immunology • Ischemic stroke • Leukemia • Pulmonary Embolism • Respiratory Diseases

Toxicity from asparaginase during acute lymphoblastic leukemia induction: A report from the Children's Oncology Group. (PubMed, Blood Adv) - P3 | "Induction data were examined from 4,925 patients ages 1-30 years enrolled in the Children's Oncology Group ALL trials AALL0232 and AALL0434, which included a single dose of pegaspargase (2,500 IU/m2) without a maximum dose...Preventive strategies are indicated for older patients and for those with obesity and high BSA but not with high BSA alone. NCT00075725, NCT00408005."

Journal • Acute Lymphocytic Leukemia • Cardiovascular • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Leukemia • Obesity • Oncology • Pancreatitis • Thrombosis

Safety and Feasibility of the CALGB 10403 Pediatric-Inspired Regimen in Adults With Acute Lymphoblastic Leukemia Older Than 40 Years (SOHO 2026) - "In patients >50 years, modifications included delayed and dose-reduced asparaginase (pegaspargase 1000 IU/m2 on day 18) and prednisone (60 mg/m2 for 22 days)... Despite a higher comorbidity burden, patients aged ≥40 years achieved equivalent outcomes across all efficacy and safety end points. These findings support extending pediatric-inspired ALL therapy beyond the traditional age cutoff. Prospective studies are warranted to confirm these results."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Systematic Literature Review and Network Meta-Analyses of Hypersensitivity in Patients Receiving Asparaginase Treatment (SOHO 2026) - " The weighted mean (min–max) rate of HSRs varied across formulations in the SLR: native ERW-ASP, 6.2% (6%–37%; n = 8 studies); pegaspargase, 9.9% (0%–55%; n = 141); calaspargase, 19% (1%–48%; n = 11); and L-asparaginase, 28.4% (0%–100%; n = 100)... Hypersensitivity risk varied across formulations, and there was little evidence of clinical benefit from premedication or desensitization. These analyses are limited by the number and size of the underlying studies, especially for calaspargase (despite its first-line setting use), warranting further research. HEORO: a health economics and outcomes research database, max: maximum, min: minimum."

Clinical • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

AALL1631: Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=352 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial primary completion date: Sep 2027 ➔ Jun 2026

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • CSF1R • PDGFRA • PDGFRB

ALL Backbone in AYAs (clinicaltrials.gov) - P2 | N=67 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK/T-Cell Lymphoma (clinicaltrials.gov) - P2 | N=620 | Not yet recruiting | Sponsor: Fudan University

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

A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102) (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Mar 2026 | Trial primary completion date: Sep 2022 ➔ Aug 2025

Trial completion • 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

Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Rong Tao | Recruiting ➔ Completed

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

Pegaspargase Rechallenge Following Grade 2 Hypersensitivity Reaction in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 16-001. (PubMed, Pediatr Blood Cancer) - "Among those who underwent rechallenge, the rechallenge dose was successfully administered (without reaction and with adequate SAA) in 41.3% of patients. This approach reduces the number of patients requiring switch to alternative asparaginase formulations, which have had limited availability and require frequent dosing."

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

Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL (clinicaltrials.gov) - P=N/A | N=61 | Completed | Sponsor: Rong Tao | Recruiting ➔ Completed

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

A Phase Ib Dose-Finding and Safety Study of Lisaftoclax Combined with a Pediatric-Inspired Chemotherapy Regimen in Adult Acute Lymphoblastic Leukemia (ALL) (ChiCTR) - P1 | N=30 | Not yet recruiting | Sponsor: The First Hospital of China Medical University; The First Hospital of China Medical University

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • T Acute Lymphoblastic Leukemia