Truxima (rituximab-abbs) / Indukern, Teva, Mundipharma, Celltrion, Nippon Kayaku - LARVOL DELTA

Differences in insurer payments for hematology part B drugs between traditional Medicare and Medicare advantage (ASH 2025) - "Thelargest relative payment differences were observed for rituximab-pvvr (34.4% higher in MedicareAdvantage; 95% CI, 26.5% to 42.4%; p < 0.001), elotuzumab (31.4% higher in Medicare Advantage; 95% CI,0.1% to 62.8%; p < 0.001), and rituximab-abbs (31.4% higher in Medicare Advantage; 95% CI, 20.6% to42.2%; p < 0.001). Payment differences were the most similar between traditional Medicare and MedicareAdvantage for rituximab (3.1% higher in Medicare Advantage; 95% CI, -2.4% to 8.7%; p < 0.001) anddaratumumab (8.2% higher in Medicare Advantage; 95% CI, 0.6% to 15.8%; p < 0.001). While payments in traditional Medicare are well established, negotiated payments inMedicare Advantage are unknown and have implications for patient affordability and physician payment.We find that each drug in our sample is paid at a higher rate in Medicare Advantage than traditionalMedicare, suggesting that Medicare Advantage beneficiaries may be responsible for greater..."

Medicare • Reimbursement • US reimbursement • Hematological Disorders

Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Yazeed Sawalha | N=24 ➔ 38 | Trial completion date: Oct 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Enrollment change • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Multimodal mass spectrometric characterization of structural microheterogeneity in rituximab reference and biosimilars. (PubMed, Int J Biol Macromol) - "Three biosimilars to Rituxan® (rituximab)-Truxima®, Ruxience®, and Riabni™-have received FDA approval. Since commercially available biosimilars were analyzed, the observed variations reflect real-world analytical variability that does not impact clinical performance. These findings, which offer detailed analytical comparisons of biosimilars, provide insights into acceptable structural variation and support efforts to refine regulatory assessment practices."

Journal

S2005: Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (clinicaltrials.gov) - P2 | N=92 | Suspended | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Suspended

Trial suspension • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

ECOG-ACRIN E1912: Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P3 | N=529 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2026 ➔ Oct 2026

Trial completion date • Anemia • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CCND1 • CD20 • CD4 • CD5 • FCER2 • IGH

Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jun 2028 ➔ Nov 2025 | Trial primary completion date: Jun 2028 ➔ Nov 2025

Trial completion • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Transplantation • CD34

Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: University of Washington

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

Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial (clinicaltrials.gov) - P3 | N=102 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma

Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Pediatrics • Transplantation • CD20

BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Christine Ryan | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2025 ➔ Apr 2025

Enrollment open • Trial initiation date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Effectiveness and Safety of Rituximab Biosimilars in Small Vessel Vasculitis: a Systematic Literature Review (ACR Convergence 2025) - "Most studies reported on the biosimilar Truxima (n=6), while Ruxience, Acelbia and Reditux were evaluated in one study each, and biosimilar type was not indicated in one abstract. We did not identify any randomized studies of biosimilar rituximab for small-vessel vasculitis, and observational data is limited. The biosimilars studied in AAV appear to have safety and effectiveness similar to historical randomized controlled trials and observational studies of the originator molecule."

Clinical • Review • ANCA Vasculitis • Hematological Disorders • Immunology • Infectious Disease • Neutropenia • Vasculitis

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 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2028 ➔ Mar 2029 | Trial primary completion date: Apr 2028 ➔ Mar 2029

Enrollment open • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Pediatrics

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=15 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=44 ➔ 15 | Trial completion date: Mar 2027 ➔ Oct 2025 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2027 ➔ Oct 2025; <75% participation

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Transplantation • CD22 • HLA-B • HLA-C • HLA-DRB1

Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: University of California, San Diego | N=20 ➔ 4

Enrollment change • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Jun 2026

Enrollment open • Trial initiation date • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology • BRAF

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR

Adverse events in patients with multiple sclerosis on Rituximab versus biosimilar in a large racial-ethnically diverse community cohort (ECTRIMS 2025) - "In this diverse MS cohort, rituximab-abbs had lower odds of adverse events (OR 0.40, 95% CI 0.34-0.47) than rituximab, with fewer emergency visits, steroid use, and infections, suggesting better tolerability despite higher incidence of hypogammaglobulinemia. Rituximab had higher acute adverse events but less hypogammaglobulinemia. Further analysis is needed to assess efficacy."

Adverse events • Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: Barbara Ann Karmanos Cancer Institute | Trial completion date: Jun 2025 ➔ Jul 2026

Trial completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • MYC

Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: University of Washington | Trial completion date: Dec 2025 ➔ Sep 2024 | Active, not recruiting ➔ Terminated; Study terminated to end of funding.

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

Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Gottfried von Keudell, MD PhD | Trial primary completion date: Feb 2025 ➔ Feb 2027

Trial primary completion date • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Thomas Jefferson University | Trial completion date: Jun 2025 ➔ Apr 2027

Trial completion date • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A051901: Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma (clinicaltrials.gov) - P1 | N=47 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: May 2027 ➔ May 2028

Trial completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD20 • MYC

NCI-2018-01198: Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2027 ➔ Dec 2026

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