Leunase (L-asparaginase) / Kyowa Kirin - LARVOL DELTA

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=669 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2025 ➔ Sep 2026

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

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov) - P3 | N=280 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Jul 2025 ➔ Jun 2026

Trial completion date • Acute Myelogenous Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • GATA1

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=669 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Sep 2025

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

AALL0631: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=218 | Completed | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov) - P3 | N=280 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Jun 2024 ➔ Jul 2025

Trial completion date • Acute Myelogenous Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • GATA1

Asparagine deprivations enhance CD8+ T cell antitumor activity and ICB immunotherapy via ROS-mediated NFAT nuclear localization (AACR 2024) - "In patients with nasopharyngeal carcinoma (NPC), leunase therapy enhances the cytokines production and activation of CD8+ T cell. In summary, our findings offer valuable insights into how T cells adapt to changes in their nutritional environment."

Nasopharyngeal Carcinoma • Oncology • Solid Tumor • CD8

AALL0434: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma (clinicaltrials.gov) - P3 | N=1895 | Active, not recruiting | Sponsor: National Cancer Institute (NCI)

Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD2 • CD20 • CD22 • CD34 • CD5 • CD7 • CD8 • MPO

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov) - P3 | N=1400 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=669 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2024 ➔ Sep 2024

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

AALL0631: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=218 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Jul 2023 ➔ Jun 2024

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • FLT3

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=669 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2023 ➔ Apr 2024

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

DP-9024, an investigational small molecule modulator of the integrated stress response kinase GCN2, synergizes with asparaginase therapy in leukemic tumors (AACR 2023) - "In vivo asparagine depletion by Leunase (L-asparaginase) led to upregulation of ATF4 in leukemia tumors in a PK/PD xenograft model and oral dosing of DP-9024 reversed Leunase-mediated upregulation of tumoral ATF4 down to basal levels. The ISR kinase GCN2 was identified as a resistance mechanism to ASNase in ASNS-low leukemic cells. Inhibition of the ISR pathway through the potent and selective small molecule modulator of GCN2, DP-9024, synergized with ASNase and re-sensitized leukemic cells to amino acid withdrawal in vitro as well as in leukemic xenograft models in vivo."

Hematological Malignancies • Leukemia • Oncology • Solid Tumor • ATF4

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=669 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2030 ➔ Jun 2023

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

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov) - P3 | N=312 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • GATA1

AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=670 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2022 ➔ Dec 2030

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

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov) - P3 | N=312 | Recruiting | Sponsor: Children's Oncology Group | Trial primary completion date: Jun 2023 ➔ Sep 2025

Trial primary completion date • Acute Myelogenous Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • GATA1

ASPARAGINASE ACTIVITY AND ANTI- E. COLI ASPARAGINASE ANTIBODY LEVEL MONITORING FOR DIFFERENT ASPARAGINASE PREPARATIONS IN HONG KONG CHILDHOOD ALL PATIENTS (EHA 2019) - "Patients allergic to Leunase were either clinically hypersensitive or silently inactivated to Oncaspar, suggesting that Oncaspar may not be a suitable alternative after Leunase allergy while the two brands of Erwinia asparaginase displayed satisfactory efficacy without triggering much hypersensitive response. Given the specificity and sensitivity, measurement of asparaginase activity should be part of the clinical monitoring to ensure adequate efficacy of different preparations."

Clinical