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

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: International Extranodal Lymphoma Study Group (IELSG) | Initiation date: Jun 2019 ➔ Sep 2019

Trial initiation date • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD20

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: International Extranodal Lymphoma Study Group (IELSG) | Recruiting ➔ Active, not recruiting

Enrollment closed • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD20

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: International Extranodal Lymphoma Study Group (IELSG) | Trial primary completion date: Jun 2024 ➔ Jun 2027

Trial primary completion date • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD20

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: International Extranodal Lymphoma Study Group (IELSG)

New P2 trial • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD20

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: International Extranodal Lymphoma Study Group (IELSG) | Not yet recruiting ➔ Recruiting

Enrollment open • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD20

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=546 | Not yet recruiting | Sponsor: Acerta Pharma BV

New P3 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=635 | Active, not recruiting | Sponsor: Acerta Pharma BV | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Oct 2025 | Trial primary completion date: Apr 2023 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=546 | Recruiting | Sponsor: Acerta Pharma BV | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=546 | Recruiting | Sponsor: Acerta Pharma BV | Trial completion date: Apr 2023 ➔ Nov 2022

Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=546 | Recruiting | Sponsor: Acerta Pharma BV | Trial completion date: Apr 2023 ➔ Feb 2024

Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov) - P3 | N=635 | Active, not recruiting | Sponsor: Acerta Pharma BV | Trial completion date: Oct 2025 ➔ Feb 2027 | Trial primary completion date: Oct 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20 • CD5 • PAX5

CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

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

Subcutaneous Epcoritamab with Rituximab + Lenalidomide in Patients with Relapsed or Refractory Follicular Lymphoma:Phase 1/2 Trial Update (ASH 2022) - P1b/2 | "All CRS events resolved (median time to resolution, 2 d; range, 1–4), no patients discontinued treatment due to CRS, and 5 patients received tocilizumab. In patients with R/R FL, subcutaneous epcoritamab + R2 demonstrated a manageable safety profile with only low-grade CRS events, mostly observed following the first full dose and all of which resolved. No new safety signals were detected. Data from this cohort are very encouraging with a high CMR rate observed in patients with R/R FL."

Clinical • P1/2 data • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • CD20

Randomized Phase III Trial Evaluating Subcutaneous Rituximab for the First-Line Treatment of Low-Tumor Burden Follicular Lymphoma: Results of a LYSA Study. (PubMed, J Clin Oncol) - "SC rituximab improves PFS for patients with low-tumor burden FL when used in induction followed by short maintenance. High rituximab exposure during the first 3 months after treatment initiation is, however, the only parameter influencing patient outcomes."

Journal • P3 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

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: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Dec 2026

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

Standing Still: A Case of Stiff Person Syndrome and Common Variable Immunodeficiency. (PubMed, Cureus) - "This case emphasizes the importance of immunologic evaluation in refractory SPS and demonstrates that combined IVIG and rituximab can provide functional benefit while addressing CVID. Transition to SCIG may stabilize IgG exposure and sustain clinical gains. A timeline of diagnoses and treatments highlights the interplay between autoimmunity and hypogammaglobulinemia and supports a tailored, multidisciplinary strategy."

Journal • CNS Disorders • Immunology • Infectious Disease • Pneumonia • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases

Outcomes from the Multicenter ACCRU-LY-1804/CARiBOU (Cytarabine, Acalabrutinib and Rituximab integrated with Bortezomib-based Outpatient therapy) Trial in 1st line Mantle Cell Lymphoma (ASH 2025) - "VR-CAP (cycles 1, 3, and 5) employed bortezomib 1.3 mg/m² subcutaneously days1,8, and 15; rituximab 375 mg/m² day 1; cyclophosphamide 750 mg/m² day 1; doxorubicin 50 mg/m2 day1; and prednisone 100 mg PO days 1-5. CARiBOU is an efficient, highly effective outpatient regimen for 1st line MCL, employingintermediate dose cytarabine with continuous acalabrutinib. With supportive care and plateletmonitoring, this approach safely yielded high rates of CMR and uMRD6, supporting multitargetedinduction therapy for appropriate pts with untreated MCL."

Clinical • Atrial Fibrillation • CNS Disorders • Febrile Neutropenia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Thrombocytopenia • TP53

Initial treatment of chronic lymphocytic leukemia with low-dose high-frequency rituximab followed by addition of acalabrutinib (ASH 2025) - P2 | "Thirty-eight untreated CLL patients with progressive disease received 50 mg intravenous (IV) rituximab oncycle 1 day 1 (C1D1), followed by 50 mg of subcutaneous (SQ) rituximab 48h later (C1D3), and then 50 mgSQ rituximab twice weekly for 23 weeks. One week of low dose rituximab effectively reduced CLL tumor burden. Clearance of circulating CLL cellsstopped within 1h of initiation of first rituximab IV dose. This was not due to insufficient serum rituximab,low serum complement, or loss of CLL cell CD20."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • CD20 • MS4A1

Subcutaneous rituximab in the treatment of primary CNS lymphoma: a retrospective case series (SNO 2025) - "Subcutaneous rituximab appears well-tolerated and potentially more cost-effective in achieving durable complete responses. Larger studies are needed to confirm these results."

Retrospective data • B Cell Lymphoma • Brain Cancer • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Solid Tumor

Subcutaneous rituximab in the treatment of primary CNS lymphoma: a retrospective case series (WFNOS 2025) - P=N/A, P2 | "Subcutaneous rituximab appears well-tolerated and potentially more cost-effective in achieving durable complete responses. Larger studies are needed to confirm these results."

Retrospective data • B Cell Lymphoma • Brain Cancer • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Solid Tumor

A Phase 1 Study of Subcutaneous Rituximab Hyaluronidase Combined with Local Standard-of-Care Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda (ASH 2023) - "The first cohort (n=6) received IV rituximab, 375mg/m2 on day 1 of cycle 1 plus CHOP chemotherapy (IV cyclophosphamide 750 mg/m2, IV doxorubicin 50 mg/m2, IV vincristine 1·4 mg/m2 (maximum 2 mg/m2) on day 1, and oral prednisone 100 mg on days 1-5). As demonstrated in other parts of the world, sqR together with CHOP chemotherapy was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high CR, PFS, and OS rates are nearly double that of historical controls at the UCI, and comparable to outcomes expected in resource-rich settings. Colleagues have previously demonstrated the safety and efficacy of an oral chemotherapy regimen for aggressive non-Hodgkin's lymphoma in East Africa (Mwanda et al."

P1 data • Anorexia • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • CD4

EPCORE FL-1: Phase 3 Trial of Subcutaneous Epcoritamab with Rituximab and Lenalidomide (R2) Vs R2 Alone in Patients with Relapsed or Refractory Follicular Lymphoma (ASH 2023) - P1/2, P3 | "Exploratory endpoints include assessments of pharmacodynamic and pharmacokinetic data. The study opened for enrollment in 2022 in North America, South America, Europe, Africa, Asia, and Australia."

Clinical • P3 data • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s 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

AVOIDED DRUG COST BY ENROLLING PATIENTS WITH HEMATOLOGICAL DISEASES IN CLINICAL TRIALS: A SINGLE CENTER EXPERIENCE (SIE 2025) - "Thanks to an academic clinical trial 13 patients with Acute Myeloid Leukemia received gemtuzumab ozogamicin, avoiding around € 270.000 of SOC therapy...This allowed us to avoid the costs of drugs such as polatuzumab vedotin (more than 70.000€ enrolling 2 patients), intravenous and subcutaneous rituximab, liposomal doxorubicin, bendamustine and lenalidomide. Our analysis demonstrates the significant economic benefit of enrolling patients with hematological diseases in clinical trials. Participation in clinical trials not only reduces the direct pharmaceutical load on the Hematology Department budget, but also allows securing grants, reimbursements, and payments, factors not assessed in this analysis."

Clinical • Drug cost • HEOR • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s 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 | 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