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DRUG:

Spectrila (asparaginase Escherichia coli)

i
Other names: MC0707, MC1003, rASNase, ASNase
Associations
Company:
Medac
Drug class:
Aspartate-ammonia ligase inhibitor, Amidohydrolase stimulant
Associations
4ms
Trial completion date
|
GATA1 (GATA Binding Protein 1)
|
cytarabine • etoposide IV • daunorubicin • mitoxantrone • mercaptopurine • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
4ms
Trial completion
|
cytarabine • cyclophosphamide • etoposide IV • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • lestaurtinib (CEP-701) • mercaptopurine • Hemady (dexamethasone tablets) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Neupogen (filgrastim) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
7ms
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD22 (CD22 Molecule) • CD34 (CD34 molecule) • CD5 (CD5 Molecule) • CD7 (CD7 Molecule) • CD2 (CD2 Molecule) • MPO (Myeloperoxidase)
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CD22 expression
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cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • nelarabine • mercaptopurine • thioguanine • Hemady (dexamethasone tablets) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexamethasone injection
8ms
Enrollment closed
|
FLT3 (Fms-related tyrosine kinase 3)
|
Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane
1year
AALL0631: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P3, N=218, Active, not recruiting, Children's Oncology Group | Trial completion date: Jul 2023 --> Jun 2024
Trial completion date
|
FLT3 (Fms-related tyrosine kinase 3)
|
cytarabine • cyclophosphamide • etoposide IV • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • lestaurtinib (CEP-701) • mercaptopurine • Hemady (dexamethasone tablets) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Neupogen (filgrastim) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
over1year
Quality comparison of a state-of-the-art preparation of a recombinant L-asparaginase derived from Escherichia coli with an alternative asparaginase product. (PubMed, PLoS One)
In the present study, we compared a recombinant E. coli-derived ASNase marketed in Europe (Spectrila®) with an E. coli-derived ASNase preparation from India (Onconase) marketed in Eastern European countries. Our results reveal that Spectrila® met all of the testing parameters, stood out for its excellent quality and, thus, represents a safe treatment option in ALL. These findings are particularly important for low- and middle-income countries, where access to ASNase formulations is limited.
Journal
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Onconase (ranpirnase) • Spectrila (asparaginase Escherichia coli)
over1year
AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P3, N=669, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Apr 2024
Trial completion date
|
cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • methotrexate • vincristine • mitoxantrone • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine • Hemady (dexamethasone tablets) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
4years
Clinical • Trial primary completion date
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GATA1 (GATA Binding Protein 1)
|
cytarabine • etoposide IV • daunorubicin • mitoxantrone • mercaptopurine • thioguanine • Erwinase (erwinia L-asparaginase) • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli)
4years
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov)
P3, N=1400, Recruiting, Children's Oncology Group | Trial completion date: Feb 2025 --> Sep 2027 | Trial primary completion date: Feb 2025 --> Sep 2027
Clinical • Trial completion date • Trial primary completion date
|
FLT3 (Fms-related tyrosine kinase 3)
|
Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Erwinase (erwinia L-asparaginase) • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • dexrazoxane
over4years
Clinical • Enrollment open
|
FLT3 (Fms-related tyrosine kinase 3)
|
Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Erwinase (erwinia L-asparaginase) • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • dexrazoxane
over4years
Clinical • Enrollment closed
|
FLT3 (Fms-related tyrosine kinase 3)
|
cytarabine • etoposide IV • methotrexate • vincristine • prednisone • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • lestaurtinib (CEP-701) • mercaptopurine • Kidrolase (L-asparaginase) • Neupogen (filgrastim) • Spectrila (asparaginase Escherichia coli) • cyclophosphamide intravenous
over4years
Clinical • New P3 trial
|
FLT3 (Fms-related tyrosine kinase 3)
|
Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Erwinase (erwinia L-asparaginase) • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • dexrazoxane
almost5years
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov)
P3, N=1641, Active, not recruiting, National Cancer Institute (NCI) | Completed --> Active, not recruiting | Trial completion date: Mar 2019 --> Sep 2027
Clinical • Enrollment closed • Trial completion date
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FLT3 (Fms-related tyrosine kinase 3)
|
FLT3-ITD mutation
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sorafenib • cytarabine • bortezomib • etoposide IV • daunorubicin • mitoxantrone • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli)