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)

5ms

AALL0631: Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov)

P3, N=218, Completed, Children's Oncology Group | Active, not recruiting --> Completed

5 months ago

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)

9ms

AALL0434: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma (clinicaltrials.gov)

P3, N=1895, Active, not recruiting, National Cancer Institute (NCI)

9 months ago

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)

CD22 expression

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

9ms

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, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting

9 months ago

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

over1year

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

over 1 year ago

Trial completion date

FLT3 (Fms-related tyrosine kinase 3)

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.

over 1 year ago

Journal

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

over 1 year ago

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

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (clinicaltrials.gov)

P3, N=256, Recruiting, Children's Oncology Group | Trial primary completion date: Mar 2023 --> Jun 2023

4 years ago

Clinical • Trial primary completion date

GATA1 (GATA Binding Protein 1)

cytarabine • etoposide IV • daunorubicin • mitoxantrone • mercaptopurine • thioguanine • Erwinase (erwinia 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

4 years ago

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 asparaginase) • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • dexrazoxane

over4years

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 | Not yet recruiting --> Recruiting

over 4 years ago

Clinical • Enrollment open

FLT3 (Fms-related tyrosine kinase 3)

over4years

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 | Completed --> Active, not recruiting

over 4 years ago

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

almost5years

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, Not yet recruiting, Children's Oncology Group

almost 5 years ago

Clinical • New P3 trial

FLT3 (Fms-related tyrosine kinase 3)

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

almost 5 years ago

Clinical • Enrollment closed • Trial completion date

FLT3 (Fms-related tyrosine kinase 3)

FLT3-ITD mutation

sorafenib • cytarabine • bortezomib • etoposide IV • daunorubicin • mitoxantrone • Kidrolase (L-asparaginase) • Spectrila (asparaginase Escherichia coli)