Spectrila (asparaginase Escherichia coli) / Medac - LARVOL DELTA

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 2026 ➔ Jun 2027

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

INTRAVENOUS VERSUS INTRAMUSCULAR ADMINISTRATION OF RECOMBINANT E. COLI ASPARAGINASE IN PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA: A RANDOMIZED COMPARATIVE STUDY (EHA 2026) - "Both intravenous (IV) and intramuscular (IM) routes are used in clinical practice; however, prospective comparative data for recombinant E. coli asparaginase (Spectrila®) remain limited...These data suggest that both IV and IM administration of recombinant E. coli asparaginase provide adequate systemic enzyme activity during consolidation therapy in pediatric ALL and may be used interchangeably based on clinical considerations and treatment logistics. Larger, adequately powered prospective studies are required to confirm these results and to further evaluate potential differences in pharmacokinetics, immunogenicity, and clinical outcomes between administration routes."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Pediatrics

AAML1031: Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P3 | N=1645 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Sep 2027 ➔ Mar 2026

Trial completion • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Sarcoma • Solid Tumor

PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia (clinicaltrials.gov) - P2 | N=40 | Terminated | Sponsor: medac GmbH | Trial completion date: May 2026 ➔ Dec 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ Nov 2025; Early termination

Trial completion date • Trial primary completion date • Trial termination • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

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

Physicochemical quality assessment of four asparaginases. (PubMed, PLoS One) - "Out of four ASNase preparations tested in this study, only Spectrila® did not raise any quality concerns. The other three products exhibited quality problems, rendering them unsuitable according to established quality requirements defined in European and US guidelines for pharmaceutical development of parenteral drug products."

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

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

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

Quality comparison of a state-of-the-art preparation of a recombinant L-asparaginase derived from Escherichia coli with an alternative asparaginase product. (PubMed, PLoS One) - "In the present study, we compared a recombinant E. coli-derived ASNase marketed in Europe (Spectrila®) with an E. coli-derived ASNase preparation from India (Onconase) marketed in Eastern European countries. Our results reveal that Spectrila® met all of the testing parameters, stood out for its excellent quality and, thus, represents a safe treatment option in ALL. These findings are particularly important for low- and middle-income countries, where access to ASNase formulations is limited."

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

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

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

"ALL-T: how do you use Spectrila, same scheme as Kidrolase or less?#spectrila # ALL-T @AaronGoodman33 @smbenlazar @nihardesai7 @melmehdi" (,@rabiihouda)

PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: medac GmbH | Active, not recruiting ➔ Recruiting

Enrollment open • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: medac GmbH | Trial completion date: Apr 2023 ➔ May 2026 | Trial primary completion date: Mar 2022 ➔ May 2025

Trial completion date • Trial primary completion date • 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

PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: medac GmbH; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

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 primary completion date: Dec 2022 ➔ Jun 2021

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