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    DRUG:

    Belrapzo (bendamustine RTD)

    i
    Other names: EP-3101
    Company:
    Eagle Pharma, SymBio Pharma
    Drug class:
    Alkylating agent
    Related drugs:
    30d
    waveLINE-003: A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (clinicaltrials.gov)
    P2/3, N=290, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 --> Sep 2027 | Trial primary completion date: Jun 2027 --> Sep 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • Truxima (rituximab-abbs) • zilovertamab vedotin (MK-2140) • Belrapzo (bendamustine RTD)
    1m
    MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Fox Chase Cancer Center | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    Rituxan (rituximab) • bendamustine • Truxima (rituximab-abbs) • Belrapzo (bendamustine RTD) • ondansetron intravenous
    3ms
    MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Fox Chase Cancer Center
    New P2 trial
    |
    Rituxan (rituximab) • bendamustine • Truxima (rituximab-abbs) • Belrapzo (bendamustine RTD) • ondansetron intravenous
    4ms
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=95, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    7ms
    A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (clinicaltrials.gov)
    P2/3, N=260, Recruiting, Merck Sharp & Dohme LLC | N=420 --> 260 | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Dec 2025 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • zilovertamab vedotin (MK-2140) • Belrapzo (bendamustine RTD)
    7ms
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=95, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    8ms
    Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=135, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD4 (CD4 Molecule)
    |
    bortezomib • bendamustine • Arzerra (ofatumumab) • Belrapzo (bendamustine RTD)
    8ms
    A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies (clinicaltrials.gov)
    P3, N=0, Withdrawn, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=200 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Rituxan (rituximab) • cyclophosphamide • Zydelig (idelalisib) • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV • Belrapzo (bendamustine RTD)
    9ms
    ALLIANCE A041202: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3, N=547, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • bendamustine • Belrapzo (bendamustine RTD) • Mabtas (rituximab biosimilar)
    9ms
    Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    cyclophosphamide • etoposide IV • fludarabine IV • Belrapzo (bendamustine RTD) • CD19 CAR T cells
    10ms
    A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies (clinicaltrials.gov)
    P3, N=200, Not yet recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    New P3 trial
    |
    Rituxan (rituximab) • cyclophosphamide • Zydelig (idelalisib) • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV • Belrapzo (bendamustine RTD)
    over1year
    Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (clinicaltrials.gov)
    P3, N=82, Terminated, MEI Pharma, Inc. | N=534 --> 82 | Trial completion date: Sep 2031 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Mar 2023; Discontinuation of zandelisib program
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Belrapzo (bendamustine RTD) • zandelisib (ME-401)
    over1year
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=95, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    over1year
    ALLIANCE A041202: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3, N=547, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2023 --> Jan 2024
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • bendamustine • Belrapzo (bendamustine RTD)
    almost2years
    Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (clinicaltrials.gov)
    P3, N=534, Active, not recruiting, MEI Pharma, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Belrapzo (bendamustine RTD) • zandelisib (ME-401)
    almost2years
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=95, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    almost2years
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=95, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    over2years
    Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
    Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    cyclophosphamide • etoposide IV • fludarabine IV • Belrapzo (bendamustine RTD) • CD19 CAR T cells
    over2years
    Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, City of Hope Medical Center | N=54 --> 37 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    cyclophosphamide • etoposide IV • fludarabine IV • Belrapzo (bendamustine RTD) • CD19 CAR T cells
    almost3years
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=103, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    almost3years
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=103, Recruiting, National Cancer Institute (NCI) | N=150 --> 103
    Enrollment change
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    5years
    A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open • Clinical
    |
    CCND1 (Cyclin D1) • CD34 (CD34 molecule)
    |
    CCND1 expression
    |
    clonoSEQ
    |
    Rituxan (rituximab) • cytarabine • Calquence (acalabrutinib) • bendamustine • Belrapzo (bendamustine RTD) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar)
    5years
    A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov)
    P2; N=369; Not yet recruiting; Sponsor:ECOG-ACRIN Cancer Research Group
    New P2 trial • Clinical
    |
    CCND1 (Cyclin D1) • CD34 (CD34 molecule)
    |
    CCND1 expression
    |
    clonoSEQ
    |
    Rituxan (rituximab) • cytarabine • Calquence (acalabrutinib) • bendamustine • Belrapzo (bendamustine RTD) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar)