Jylamvo (methotrexate oral solution) / Shorla Oncology - LARVOL DELTA

AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P2 | N=461 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting | N=300 ➔ 461

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Oncology • CD19

A Study Comparing the Combination of Dasatinib or Imatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P3 | N=222 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | N=680 ➔ 222

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • CD19 • CSF1R • KIT • PDGFRA • PDGFRB

Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Oncology • Oral Cancer

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=153 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting

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

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P3 | N=435 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Jun 2026 | Trial primary completion date: Dec 2027 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • BCR • CEBPA • FLT3 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1 • NPM1

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=1186 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

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

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

Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (clinicaltrials.gov) - P2 | N=53 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Pediatrics

Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome (clinicaltrials.gov) - P2 | N=22 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute

New P2 trial • Hematological Malignancies • Oncology

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

NCI-2020-01626: Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | N=45 ➔ 60

Enrollment change • Myelofibrosis • Transplantation

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=97 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • ABL1 • ANPEP • BCR • CD22 • CD5 • CD7 • CD79A • MME • MPO

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

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

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

Shorla Oncology Announces U.S. Food and Drug Administration (FDA) Expanded Approval of JYLAMVO (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications (Businesswire) - "Shorla Oncology...announced today that the U.S. Food and Drug Administration (FDA) has expanded the approval of JYLAMVO (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). With this approval, JYLAMVO is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications."

FDA approval • Acute Lymphocytic Leukemia • Idiopathic Arthritis

Shorla Oncology & EVERSANA Announce U.S. Commercial Launch of FDA-Approved JYLAMVO, the First and Only Oral Methotrexate Solution Approved in the U.S. for Adults (PRNewswire) - "Shorla Oncology...and EVERSANA...today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste and is approved to treat adults with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen; mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; rheumatoid arthritis; and severe psoriasis....EVERSANA, the commercialization partner to Shorla, will provide comprehensive launch support including field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, agency solutions, patient services, data and analytics, third-party logistics channel and trade relations support."

Launch US • Acute Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Hematological Malignancies • Immunology • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Psoriasis • Rheumatoid Arthritis • T Cell Non-Hodgkin Lymphoma

Does Methotrexate Increase Skin Cancer Risk? (RheumNow) - "There are several reports suggesting a link between methotrexate (MTX) use and certain skin cancers, yet these are confounded by a higher risk of skin cancers with inflammatory conditions like rheumatoid arthritis of which MTX is the most common treatment....either from their inflammatory disorder or MTX. As such, these patients should undergo regular skin cancer screening."

Online posting

Serious Infection Risk in Pediatric Psoriasis with Ustekinumab, Etanercept, or Methotrexate (RheumNow) - "Etanercept was FDA approved for use in pediatric psoriasis (PsO) in 2016 and ustekinumab was similarly approved in 2020. This comparative analysis looks at the risk of serious infections (SIE) requiring hospitalization in pediatric PSO patients treated with ustekinumab, etanercept, or methotrexate prior to 2016....Pediatric psoriasis treated with immunomodulating agents infrequently causes serious infections, with little difference between etanercept, ustekinumab or MTX."

Online posting

New Approvals for GVHD Expand Treatment Options - "These medications have a pediatric indication, 'whereas ibrutinib [Imbruvica, Pharmacyclics/Janssen] is only approved for adult patients,' observed Doris M. Ponce, MD...and the lead author of the 2021 Guidelines for the Prevention and Management of Graft-Versus-Host Disease After Cord Blood Transplantation of the American Society for Transplantation and Cellular Therapy Cord Blood Special Interest Group."

Media quote