Rituxan Hycela (rituximab/hyaluronidase) / Biogen, Roche, Halozyme - LARVOL DELTA

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

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: UNC Lineberger Comprehensive Cancer Center | Recruiting ➔ Active, not recruiting | N=44 ➔ 5 | Trial completion date: Aug 2028 ➔ Nov 2026 | Trial primary completion date: Aug 2028 ➔ Mar 2025

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

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

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Georgetown University | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: University of Washington | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

SUBCUTANEOUS ULTRA-LOW DOSE RITUXIMAB VERSUS INTRAVENOUS ULTRA-LOW DOSE RITUXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMISED CONTROLLED NON-INFERIORITY TRIAL (EULAR 2025) - "Although the formal primary endpoint will follow, these results show lower systemic RTX levels than expected based on the previously mentioned bioavailability. However, with a non-inferior difference in disease activity and comparable B-cell depletion, subcutaneous ultra-low dose RTX may be as effective clinically as IV ultra-low dose RTX, and could therefore be a feasible option for the treatment of rheumatoid arthritis."

Clinical • Head-to-Head • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

The cost of convenience: Evaluating economic differences in SQ and IV biotherapeutic formulations. (ASCO 2025) - " SQ formulations of Rituximab (Rituxan Hycela), Trastuzumab (Herceptin Hylecta), and Daratumumab (Darzalex Faspro) became available in 2017, 2019 and 2020, respectively. While subcutaneous (SQ) formulations offer convenience and potential clinical and administrative benefits, they generally cost more than their IV counterparts. SQ Daratumumab was more readily adopted possibly due to fewer drug-related reactions, shorter administration duration, patient convenience, and lack of biosimilar options. Despite the higher costs, convenience and patient preference for SQ formulations may justify their use in certain clinical scenarios."

Oncology

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) | Recruiting ➔ Active, not recruiting

Enrollment closed • 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

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 | Recruiting ➔ Active, not recruiting | N=30 ➔ 4 | Trial completion date: Mar 2025 ➔ Jun 2025

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

Real-World Subcutaneous Monoclonal Antibody Use Trends for Oncology in the US (ISPOR 2025) - " We analyzed de-identified data from Trisus Medication Compare (The Craneware Group, Edinburgh, UK) between 1/1/2019-12/31/2023 to identify patient encounters containing a dispensation for subcutaneous formulations of hyaluronidase with rituximab, trastuzumab, daratumumab, and combination pertuzumab and trastuzumab...The most used product was daratumumab with hyaluronidase (82.7% of dispensations), which correlates with the high rate of multiple myeloma in the sample... From 2019-2022, national data show increased use of subcutaneous monoclonal antibodies for oncology, an advantageous alternative offering opportunities to enhance patient care and improve cost and resource efficiency."

Clinical • Real-world • Real-world evidence • Amyloidosis • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Solid Tumor

Intravenous low-dose anti-CD20 Rituximab infusion contrasted with subsequent subcutaneous Rituximab injection during CLL patient treatment (IMMUNOLOGY 2025) - "Our data suggest slow SQ mAb diffusion into circulation steadily binds to CLL cells, resulting in low serum levels and slow depletion of CLL cells, with increasing serum RTX levels as SQ doses accumulate. Surviving CLL cells were still sensitive to mAb cytotoxicity, suggesting that cytotoxic effector cells were "exhausted" by RTX therapy.Keywords: Animals Human; Cells B Cells; Molecules Antibodies Antigens/Peptides/Epitopes; Processes Phagocytosis"

Clinical • Chronic Lymphocytic Leukemia

Subcutaneous rituximab in indolent primary cutaneous B cell lymphoma: A case series of 5 patients with the evaluation of the medico economic impact. (PubMed, Therapie) - No abstract available

HEOR • Journal • B Cell Lymphoma • Follicle Center Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Oncology • CCND1

Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Emory University | Trial completion date: Sep 2024 ➔ Jun 2026

Checkpoint inhibition • Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda. (PubMed, JCO Glob Oncol) - "As demonstrated in other parts of the world, sqR together with CHOP was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high OS rates are nearly double those of historical controls and comparable with outcomes expected in resource-rich settings. This study demonstrated the feasibility, safety, and efficacy of sqR-CHOP, increased the research infrastructure in Uganda, and will improve care in other resource-limited settings."

Journal • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

MCL R2: R-CHOP + R-HAD Vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab Vs Rituximab for Older Patients with MCL (clinicaltrials.gov) - P3 | N=623 | Completed | Sponsor: The Lymphoma Academic Research Organisation | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Jan 2025

Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Sep 2027 ➔ Dec 2027 | Trial completion date: Sep 2027 ➔ Dec 2027

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

LOTIS-9: A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov) - P2 | N=41 | Terminated | Sponsor: ADC Therapeutics S.A. | Completed ➔ Terminated; The benefit-risk profile does not support continuation of the LOTIS-9 trial.

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

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Georgetown University | Trial completion date: Nov 2024 ➔ Jan 2026 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Pharmacokinetics, efficacy, and safety of subcutaneous versus intravenous rituximab in previously untreated Chinese patients with CD20+ diffuse large B-cell lymphoma: a phase II randomized controlled trial. (PubMed, Leuk Lymphoma) - P2 | "Subcutaneous (SC) rituximab has demonstrated advantages over intravenous (IV) administration; however, insufficient data exist on its use with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in Chinese patients with diffuse large B-cell lymphoma (DLBCL). The complete response rate was similar in both treatment arms. SC rituximab is a viable option in Chinese patients with untreated CD20-positive DLBCL, potentially reducing administration burden (ClinicalTrials.gov identifier: NCT04660799)."

Journal • P2 data • PK/PD data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

17-BI-1206-02: A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: BioInvent International AB | N=98 ➔ 140 | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CRP

Efficacy and Safety of Subcutaneous Rituximab in Idiopathic Nephrotic Syndrome. (PubMed, Kidney Int Rep) - No abstract available

Journal • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease

Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission (clinicaltrials.gov) - P3 | N=689 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2032 ➔ Jan 2027

Enrollment closed • Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Transplantation • CCND1 • CD4 • SOX11

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Apr 2025 ➔ Oct 2024

Trial initiation date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: Academic and Community Cancer Research United | N=63 ➔ 3 | Trial completion date: Apr 2029 ➔ Mar 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2027 ➔ Mar 2024; Trial closed due to low accrual rate

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CCND1