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    DRUG:

    Erwinase (erwinia asparaginase)

    i
    Other names: OP-01
    Associations

    News

    Trials
    Company:
    Bioprofarma, Jazz, Ohara Pharma
    Drug class:
    Aspartate-ammonia ligase inhibitor, Amidohydrolase stimulant
    Related drugs:
    Associations

    News

    Trials
    1m
    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, 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
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    clonoSEQ
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    Rituxan (rituximab) • cytarabine • cyclophosphamide • methotrexate • vincristine • daunorubicin • Truxima (rituximab-abbs) • mercaptopurine • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Hemady (dexamethasone tablets) • Erwinase (erwinia asparaginase) • Mabtas (rituximab biosimilar) • Starasid (cytarabine ocfosfate)
    8ms
    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, Not yet recruiting, City of Hope Medical Center
    New P2 trial
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    clonoSEQ
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    Rituxan (rituximab) • cytarabine • cyclophosphamide • methotrexate • vincristine • daunorubicin • Truxima (rituximab-abbs) • mercaptopurine • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Hemady (dexamethasone tablets) • Erwinase (erwinia asparaginase) • Mabtas (rituximab biosimilar) • Starasid (cytarabine ocfosfate)
    over1year
    A Phase 1, Single Centre, Open Label, Single Dose, Pharmacokinetic Study of Erwinaze in Healthy Adult Volunteers (ACTRN12623000491662)
    P1, N=12, Withdrawn, Porton Biopharma Limited | Not yet recruiting --> Withdrawn
    Trial withdrawal
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    Erwinase (erwinia asparaginase)
    2years
    Oncogenetic-Driven Targeted Therapy for Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia : A French ALL-Target Observatory Report (ASH 2023)
    In relapse/refractory (R/R) patients, standard of care treatments, including nelarabine, yield response rate of about 20-40% and responses are of short duration...For example, TTOs included Tofacitinib and Venetoclax (Tofa/Ven) in case of IL7R (CD127) expression or IL7R-pathway alterations (IL7RALT), 5-azacytidine and Venetoclax (Aza/Ven) in case of T-ALL/LL with epigenetic regulators alterations (DNMT3A, ASXL1, PHF6, TET2, PRC2, IDH1/2, SRSF2...) or Temsirolimus, Erwinase and Venetoclax (Tem/Erw/Ven) in case of PI3K signaling pathway alterations (PI3KALT)...Twenty-five patients received a TTO, including 14 Aza/Ven (56%), 8 Tofa/Ven (32%), 2 Tem/Erw/Ven (8%) and 1 Trametinib/Ven (4%)...A better knowledge of the oncogenetic landscape of T-ALL, and a close collaboration between clinicians and biologists, resulted in individualized treatment strategies. With a 3 months cumulative incidence of response of 70%, TTOs appear to be a promising approach in R/R T-ALL.
    IO biomarker
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    TP53 (Tumor protein P53) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ATM (ATM serine/threonine kinase) • DNMT3A (DNA methyltransferase 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • SRSF2 (Serine and arginine rich splicing factor 2) • IL7R (Interleukin 7 Receptor) • PHF6 (PHD Finger Protein 6)
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    TP53 mutation • ATM mutation • BCL2 expression • IL7R expression
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    Venclexta (venetoclax) • Mekinist (trametinib) • azacitidine • Torisel (temsirolimus) • nelarabine • tofacitinib • Erwinase (erwinia asparaginase)
    2years
    Back to the future: the amazing journey of the therapeutic antileukemia enzyme asparaginase Erwinia chrysanthemi. (PubMed, Haematologica)
    An asparaginase product displaying the same characteristics of the Erwinia chrysanthemi asparaginase recently has been produced by use of recombinant technology, thus securing a preparation available for use as an alternative, or as a back-up in case of shortages, for the non-recombinant product. The long journey of the Erwinia chrysanthemi asparaginase product as it has developed throughout the last several decades has made it possible for almost every child and adult with ALL to complete the asparaginase-based protocol treatment when an immunological reaction has occurred to any Escherichia coli asparaginase product.
    Journal
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    Erwinase (erwinia asparaginase)
    over2years
    A Phase 1, Single Centre, Open Label, Single Dose, Pharmacokinetic Study of Erwinaze in Healthy Adult Volunteers (ACTRN12623000491662)
    P1, N=12, Not yet recruiting, Porton Biopharma Limited
    New P1 trial
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    Erwinase (erwinia asparaginase)
    almost3years
    AALL1521: A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=171, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
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    JAK2 (Janus kinase 2) • CRLF2 (Cytokine Receptor Like Factor 2) • JAK1 (Janus Kinase 1) • IL7R (Interleukin 7 Receptor) • EPOR (Erythropoietin Receptor) • SH2B3 (SH2B Adaptor Protein 3)
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    CRLF2 rearrangement • JAK2 mutation • IL7R mutation • JAK2 fusion • SH2B3 deletion
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    cytarabine • doxorubicin hydrochloride • Jakafi (ruxolitinib) • cyclophosphamide • vincristine • prednisone • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine • Erwinase (erwinia asparaginase)
    over3years
    AALL1521: A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=170, Recruiting, Incyte Corporation | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
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    JAK2 (Janus kinase 2) • CRLF2 (Cytokine Receptor Like Factor 2) • JAK1 (Janus Kinase 1) • IL7R (Interleukin 7 Receptor) • EPOR (Erythropoietin Receptor) • SH2B3 (SH2B Adaptor Protein 3)
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    CRLF2 rearrangement • JAK2 mutation • IL7R mutation • JAK2 fusion • SH2B3 deletion
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    cytarabine • doxorubicin hydrochloride • Jakafi (ruxolitinib) • cyclophosphamide • vincristine • prednisone • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine • Erwinase (erwinia asparaginase)
    over3years
    Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov)
    P3, N=312, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Jun 2024 | Trial primary completion date: Sep 2025 --> Jun 2024
    Trial completion date • Trial primary completion date
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    GATA1 (GATA Binding Protein 1)
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    cytarabine • etoposide IV • daunorubicin • mitoxantrone • thioguanine • Erwinase (erwinia asparaginase)
    over3years
    Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov)
    P3, N=312, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
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    GATA1 (GATA Binding Protein 1)
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    cytarabine • etoposide IV • daunorubicin • mitoxantrone • thioguanine • Erwinase (erwinia asparaginase)