Novex (rituximab biosimilar) / Elea Labs, Insud Pharma, NATCO, Pharmaceutical Libbs, Urufarma, PiSA Farmaceutica, Laboratorios Bioeticos - LARVOL DELTA

Long-Term Safety and Effectiveness of Rituximab Biosimilar RTXM83: A Retrospective Extension Study in Brazilian Patients with Diffuse Large B-Cell Lymphoma. (PubMed, Oncol Ther) - P=N/A | "This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care."

Journal • Retrospective data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

NOVasure EXpierences (NOVEX) (clinicaltrials.gov) - P=N/A | N=32 | Completed | Sponsor: Maxima Medical Center

New trial • Women's Health

Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab (clinicaltrials.gov) - P=N/A | N=27 | Completed | Sponsor: Libbs Farmacêutica LTDA | Not yet recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Mar 2023

Trial completion • Trial completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Retrospective Observational Study of the Long-Term Safety and Efficacy Outcomes of Rituximab Biosimilar: Partial Data of RTXM83-AC-01-11 Subanalysis Study (ASH 2022) - P | "One participant of the RTXM83-CHOP arm had a SAE classified as severe infection related to rituximab (hypogammaglobulinemia). From the R-CHOP/MabThera® 1 participant displayed 1 SAE (secondary neoplasm) with a possible relationship to rituximab.Conclusion The partial analysis of the LB2002 has demonstrated thus far the safety profile of the biosimilar RTXM83 (Vivaxxia®) in the Brazilian population is consistent with the known safety profile of rituximab."

Observational data • Retrospective data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Safety Of Rituximab Biosimilar Rtxm83 In Autoimmune Diseases. Real-World Study (PANLAR 2022) - "RR: Relative Risk Conclusion We did not find differences in the incidence of adverse events (serious and minor) of any cause in patients who received the biosimilar RTXM83 compared with the innovator rituximab, both in de novo indications and in patients who were switched between drugs. This is the first real-world study performed in Argentina"

Clinical • Real-world evidence • Immunology

Intensive Safety Monitoring of Rituximab (Biosimilar Novex and the Innovator) in Pediatric Patients With Complex Diseases. (PubMed, Front Pharmacol) - "The present is the largest real-world safety assessment of rituximab in Latin-American children with complex diseases supporting its use based on the overall acceptable safety. Identification of risk factors may contribute to optimization of off-label rituximab treatment in pediatrics."

Journal • Bone Marrow Transplantation • CNS Disorders • Hematological Disorders • Immunology • Pediatrics • Solid Organ Transplantation • Transplantation

[VIRTUAL] RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE (HEMO 2021) - "From 32 reports, 19 were female, 12 were male and 1 not informed. The patients mean age was 48.8 (13 to 81 years). The treatment indication was hematology oncology diseases in 23 (72%) patients, autoimmune disease in 7 patients (22%) and not informed in 2 (6%) patients. Regarding seriousness and expectedness AEs, 26 (44%) were non-serious AEs (24 expected / 2 unexpected) and 33 (56%) were serious AEs (22 expected / 11 unexpected). The five most frequently reported AEs according to SOC (System Organ Classification) were immune system disorders 19 (32%), blood and lymphatic system disorders 14 (24%), nervous system disorders 4 (7%), investigations 3 (5%) , respiratory, thoracic and mediastinal disorders 3 (5%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were infusion related reaction 18 (31%), neutropenia 6 (10%), anaemia 3 (5%), leukopenia 2 (3%), thrombocytopenia 2 (3% ). Conclusion AEs spontaneously reported in..."

Adverse events • P4 data • Anemia • Hematological Disorders • Immunology • Leukopenia • Neutropenia • Oncology • Thrombocytopenia

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov) - P1; N=26; Suspended; Sponsor: Mayo Clinic; Trial completion date: Dec 2020 ➔ May 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Marginal Zone Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab (clinicaltrials.gov) - P; N=28; Not yet recruiting; Sponsor: Libbs Farmacêutica LTDA

New trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Northwestern University; Trial completion date: Jun 2022 ➔ Jun 2023; Trial primary completion date: May 2021 ➔ May 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20

PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • TNFRSF8

High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov) - P2; N=20; Terminated; Sponsor: Fred Hutchinson Cancer Research Center; Active, not recruiting ➔ Terminated; Terminated due to insufficient funding

Clinical • Trial termination • Bone Marrow Transplantation • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD20

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Oct 2020 ➔ Dec 2034; Trial primary completion date: Oct 2020 ➔ Dec 2034

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Oncology

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (clinicaltrials.gov) - P2; N=44; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Mar 2021 ➔ Mar 2025; Trial primary completion date: Mar 2021 ➔ Mar 2025

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Transplantation • CD22 • HLA-DRB1

Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Northwestern University; Recruiting ➔ Active, not recruiting; N=18 ➔ 12

Clinical • Enrollment change • Enrollment closed • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL2 • BCL6 • MYC

Venetoclax, Dasatinib, Prednisone, and Rituximab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: OHSU Knight Cancer Institute; Initiation date: May 2021 ➔ Aug 2021

Clinical • Combination therapy • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2; N=208; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma

Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2; N=25; Suspended; Sponsor: University of Washington; Recruiting ➔ Suspended

Combination therapy • Trial suspension • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Carfilzomib With Bendamustine and Rituximab in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: University of California, San Francisco; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P1 trial • Diffuse Large B Cell Lymphoma • Human Immunodeficiency Virus • Infectious Disease • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Sep 2020 ➔ Jul 2023; Trial primary completion date: Sep 2020 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Trial primary completion date: Jul 2023 ➔ Sep 2021

Clinical • Enrollment open • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Aplastic Anemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Plasmacytoma • Small Lymphocytic Lymphoma • Transplantation • ASXL1 • DNMT3A • FLT3 • KMT2A • PHF6 • TET2

Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas (clinicaltrials.gov) - P2/3; N=351; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • MYC

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4