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    DRUG:

    Rituxan Hycela (rituximab/hyaluronidase)

    i
    Other names: rHuPH20/MabThera, SC MabThera, rHuPH20/rituximab, hyaluronidase/rituxmab
    Company:
    Biogen, Halozyme, Roche
    Drug class:
    CD20 inhibitor
    Related drugs:
    17d
    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, ECOG-ACRIN Cancer Research Group | Recruiting --> Active, not recruiting | Trial completion date: Jan 2032 --> Jan 2027
    Enrollment closed • Trial completion date
    |
    CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • SOX11 (SRY-Box Transcription Factor 11)
    |
    Chr t(11;14) • SOX11 expression
    |
    clonoSEQ
    |
    Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Mabtas (rituximab biosimilar)
    2ms
    Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=39, Completed, University of Rochester | Active, not recruiting --> Completed
    Trial completion
    |
    Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    2ms
    Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=3, Terminated, 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 termination • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14)
    |
    Venclexta (venetoclax) • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
    3ms
    MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov)
    P2, N=175, Active, not recruiting, International Extranodal Lymphoma Study Group (IELSG) | Trial primary completion date: Jun 2024 --> Jun 2027
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Imbruvica (ibrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    5ms
    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=30, Recruiting, Thomas Jefferson University | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase)
    6ms
    Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov)
    P3, N=244, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2028 --> Sep 2027 | Trial primary completion date: Dec 2028 --> Sep 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Opdivo (nivolumab) • Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Neulasta (pegfilgrastim) • ABP 206 (nivolumab biosimilar) • Mabtas (rituximab biosimilar) • Neupogen (filgrastim) • prednisolone
    7ms
    Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas (clinicaltrials.gov)
    P2, N=43, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P2 trial
    |
    Brukinsa (zanubrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    8ms
    Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | N=44 --> 15 | Trial primary completion date: Oct 2023 --> Sep 2024
    Enrollment closed • Enrollment change • Trial primary completion date • Checkpoint inhibition • Checkpoint block • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Rituxan Hycela (rituximab/hyaluronidase)
    8ms
    Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma (clinicaltrials.gov)
    P3, N=600, Not yet recruiting, National Cancer Institute (NCI)
    New P3 trial
    |
    Rituxan Hycela (rituximab/hyaluronidase) • Lunsumio (mosunetuzumab-axgb) • Mabtas (rituximab biosimilar)
    8ms
    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, Canadian Cancer Trials Group | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
    8ms
    Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, University of Rochester | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> May 2023
    Trial completion date • Trial primary completion date
    |
    Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    9ms
    Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=70, Recruiting, National Cancer Institute (NCI) | Initiation date: Jul 2024 --> Jan 2024
    Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    CD20 expression
    |
    Rituxan Hycela (rituximab/hyaluronidase) • Lunsumio (mosunetuzumab-axgb) • Mabtas (rituximab biosimilar)
    9ms
    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, Canadian Cancer Trials Group | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
    10ms
    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, Completed, ADC Therapeutics S.A. | Active, not recruiting --> Completed
    Trial completion
    |
    Rituxan (rituximab) • Zynlonta (loncastuximab tesirine-lpyl) • Rituxan Hycela (rituximab/hyaluronidase)
    11ms
    NCI-2019-01493: Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda (clinicaltrials.gov)
    P1, N=18, Terminated, Fred Hutchinson Cancer Center | N=40 --> 18 | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Jul 2023; Closed per SRC Low Accrual Policy
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • prednisone • daunorubicin • Rituxan Hycela (rituximab/hyaluronidase) • methotrexate IV
    11ms
    Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=44, Recruiting, UNC Lineberger Comprehensive Cancer Center
    Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
    12ms
    A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Georgetown University | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Rituxan Hycela (rituximab/hyaluronidase)
    12ms
    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=30, Recruiting, Thomas Jefferson University | Suspended --> Recruiting
    Enrollment open • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • Rituxan Hycela (rituximab/hyaluronidase)
    almost1year
    Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=70, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Oct 2026 | Initiation date: Oct 2023 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Oct 2026
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    CD20 expression
    |
    Rituxan Hycela (rituximab/hyaluronidase) • Lunsumio (mosunetuzumab-axgb) • Mabtas (rituximab biosimilar)
    1year
    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
    |
    CD4 (CD4 Molecule)
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Rituxan Hycela (rituximab/hyaluronidase)
    1year
    Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Academic and Community Cancer Research United | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14)
    |
    Venclexta (venetoclax) • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
    1year
    Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma (clinicaltrials.gov)
    P2; Trial primary completion date: Sep 2025 --> Aug 2024
    Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    clonoSEQ
    |
    cytarabine • bortezomib • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase) • Starasid (cytarabine ocfosfate)
    1year
    Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=63, Recruiting, Academic and Community Cancer Research United | Trial completion date: Dec 2025 --> Apr 2029 | Trial primary completion date: Dec 2023 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14)
    |
    Venclexta (venetoclax) • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
    1year
    Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma (clinicaltrials.gov)
    P2; Trial completion date: Aug 2025 --> Aug 2028 | Trial primary completion date: Aug 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    clonoSEQ
    |
    cytarabine • bortezomib • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase) • Starasid (cytarabine ocfosfate)
    over1year
    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.
    P3 data • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • Rituxan Hycela (rituximab/hyaluronidase)
    over1year
    Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=44, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Feb 2023
    Enrollment open • Trial initiation date
    |
    cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Polivy (polatuzumab vedotin-piiq)
    over1year
    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, 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 • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • PAX5 (Paired Box 5) • CD5 (CD5 Molecule)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Calquence (acalabrutinib) • bendamustine • Rituxan Hycela (rituximab/hyaluronidase)
    over1year
    Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Rituxan Hycela (rituximab/hyaluronidase) • Lunsumio (mosunetuzumab-axgb)
    over1year
    Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma (clinicaltrials.gov)
    P2; Trial completion date: Aug 2028 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    clonoSEQ
    |
    cytarabine • bortezomib • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase) • Starasid (cytarabine ocfosfate)
    over1year
    PHARMACOKINETICS, EFFICACY AND SAFETY OF SUBCUTANEOUS VERSUS INTRAVENOUS RITUXIMAB COMBINED WITH CHOP IN CHINESE PATIENTS WITH UNTREATED CD20-POSITIVE DIFFUSE LARGE B CELL LYMPHOMA: A RANDOMIZED TRIAL (EHA 2023)
    The standard of care for DLBCL is eight cycles of intravenous (IV) rituximab combined with six or eight cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). SC rituximab demonstrated non-inferior rituximab serum trough levels, as well as comparable efficacy and tolerability to IV rituximab in Chinese patients with previously untreated CD20+ DLBCL, indicating that SC rituximab is a viable route of administration, with potential to reduce burden of administration for healthcare professionals and patients. Non-Hodgkin's lymphoma, Diffuse large B cell lymphoma, Rituximab, DLBCL
    Clinical • PK/PD data
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Rituxan Hycela (rituximab/hyaluronidase)
    over1year
    MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov)
    P2, N=175, Active, not recruiting, International Extranodal Lymphoma Study Group (IELSG) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Imbruvica (ibrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    over1year
    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, Acerta Pharma BV | Trial completion date: Apr 2023 --> Feb 2024
    Trial completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • PAX5 (Paired Box 5) • CD5 (CD5 Molecule)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Calquence (acalabrutinib) • bendamustine • Rituxan Hycela (rituximab/hyaluronidase)
    almost2years
    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=30, Suspended, Thomas Jefferson University | Recruiting --> Suspended
    Trial suspension
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • Rituxan Hycela (rituximab/hyaluronidase)
    almost2years
    SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov)
    P2, N=5, Terminated, Epizyme, Inc. | N=59 --> 5 | Trial completion date: Sep 2026 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Jul 2026 --> Mar 2022; Decision to terminate EZH-1401 was solely due to company business decision.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit)
    |
    EZH2 mutation
    |
    Tazverik (tazemetostat) • Rituxan Hycela (rituximab/hyaluronidase)
    2years
    A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P2, N=50, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Rituxan Hycela (rituximab/hyaluronidase)
    2years
    Subcutaneous Epcoritamab with Rituximab + Lenalidomide in Patients with Relapsed or Refractory Follicular Lymphoma:Phase 1/2 Trial Update (ASH 2022)
    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
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • lenalidomide • Epkinly (epcoritamab-bysp) • Rituxan Hycela (rituximab/hyaluronidase) • Actemra IV (tocilizumab)
    2years
    Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda (clinicaltrials.gov)
    P1, N=40, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • prednisone • daunorubicin • Rituxan Hycela (rituximab/hyaluronidase) • methotrexate IV
    2years
    Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non-interventional study MabSCale. (PubMed, Cancer Med)
    The results confirmed the effectiveness and safety of rituximab SC in both the FL and the DLBCL group. Satisfaction of patients and nurses with SC administration was high.
    Observational data • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan Hycela (rituximab/hyaluronidase)
    2years
    PTLD-2: Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With Rituximab SC and Immunochemotherapy (clinicaltrials.gov)
    P2, N=60, Completed, Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jul 2022
    Trial completion • Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • oxaliplatin • prednisone • Rituxan Hycela (rituximab/hyaluronidase)
    2years
    A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. (PubMed, Pharmacoecon Open)
    This review indicated a substantial body of evidence showing time/resource and cost savings of SC versus IV administration of oncology biologics in a hospital setting, which can be used to inform economic evaluations of PH FDC SC.
    Review
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Rituxan Hycela (rituximab/hyaluronidase) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    over2years
    Subcutaneous Epcoritamab with Rituximab + Lenalidomide (R2) in Patients (PTS) with Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Update from Phase 1/2 Trial (PPLC 2022)
    All CRS events resolved with standard management, including tocilizumab in 3 pts, and 1 pt discontinued Tx due to CRS. Subcutaneous epcoritamab + R2 exhibits promising efficacy, including a high CMR rate, in pts with R/R FL. The safety profile was consistent with prior data, and CRS events were generally low grade and in C1. Updated data will be presented.
    Clinical • P1/2 data
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    lenalidomide • Epkinly (epcoritamab-bysp) • Rituxan Hycela (rituximab/hyaluronidase) • Actemra IV (tocilizumab)
    over2years
    A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Aug 2022 --> May 2022
    Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Rituxan Hycela (rituximab/hyaluronidase)