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Calaspargase pegol

Generic Name
Calaspargase pegol
Brand Names
Asparlas
Drug Type
Biotech
Chemical Formula
-
CAS Number
941577-06-6
Unique Ingredient Identifier
T9FVH03HMZ
Background

Asparaginase is an important agent used to treat acute lymphoblastic leukemia (ALL) . Asparagine is incorporated into most proteins, and the synthesis of proteins is stopped when asparagine is absent, which inhibits RNA and DNA synthesis, resulting in a halt in cellular proliferation. This forms the basis of asparaginase treatment in ALL , , .

Calaspargase pegol, also known as asparlas, is an asparagine specific enzyme which is indicated as a part of a multi-agent chemotherapy regimen for the treatment of ALL . The asparagine specific enzyme is derived from Escherichia coli, as a conjugate of L-asparaginase (L-asparagine amidohydrolase) and monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) linker to create a stable molecule which increases the half-life and decreases the dosing frequency , .

Calaspargase pegol, by Shire pharmaceuticals, was approved by the FDA on December 20, 2018 for acute lymphoblastic anemia (ALL) .

Indication

This drug is is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years .

The pharmacokinetics of calaspargase pegol were examined when given in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL . The FDA approval of this drug was based on the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when administering calaspargase, 2500 U/m2 intravenously, at 3-week intervals.

Associated Conditions
Acute Lymphoblastic Leukemia (ALL)
Associated Therapies
-

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

Phase 2
Not yet recruiting
Conditions
B Acute Lymphoblastic Leukemia
Acute Leukemia of Ambiguous Lineage
Interventions
Drug: Asparaginase Erwinia chrysanthemi
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Computed Tomography
Biological: Blinatumomab
Drug: Calaspargase Pegol
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Prednisolone
Drug: Dexamethasone
Drug: Prednisone
Drug: Doxorubicin
Procedure: Echocardiography
Procedure: FDG-Positron Emission Tomography
Drug: Leucovorin
Procedure: Lumbar Puncture
Procedure: Magnetic Resonance Imaging
Drug: Mercaptopurine
Drug: Methotrexate
Procedure: Multigated Acquisition Scan
Drug: Pegaspargase
Drug: Therapeutic Hydrocortisone
Drug: Thioguanine
Drug: Venetoclax
Drug: Vincristine
First Posted Date
2024-03-19
Last Posted Date
2024-12-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
171
Registration Number
NCT06317662

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Phase 2
Withdrawn
Conditions
T Lymphoblastic Lymphoma
T Acute Lymphoblastic Leukemia
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Calaspargase Pegol
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Dexamethasone
Drug: Doxorubicin
Procedure: Echocardiography
Procedure: Lumbar Puncture
Drug: Mercaptopurine
Drug: Methotrexate
Procedure: Multigated Acquisition Scan
Biological: Navitoclax
Drug: Pegaspargase
Drug: Nelarabine
Procedure: Positron Emission Tomography
Drug: Thioguanine
Procedure: X-Ray Imaging
Drug: Venetoclax
Drug: Vincristine
First Posted Date
2024-01-18
Last Posted Date
2024-05-17
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT06210750

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2
Suspended
Conditions
Down Syndrome
Recurrent B Acute Lymphoblastic Leukemia
Interventions
Procedure: Biospecimen Collection
Radiation: 3-Dimensional Conformal Radiation Therapy
Biological: Blinatumomab
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Drug: Dexamethasone
Drug: Calaspargase Pegol
Drug: Hydrocortisone Sodium Succinate
Procedure: Lumbar Puncture
Drug: Methotrexate
Biological: Nivolumab
Drug: Mercaptopurine
Drug: Pegaspargase
Drug: Pegcrisantaspase
Drug: Vincristine Sulfate
First Posted Date
2020-09-14
Last Posted Date
2024-10-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
300
Registration Number
NCT04546399
Locations
🇺🇸

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States

🇺🇸

Corewell Health Dearborn Hospital, Dearborn, Michigan, United States

🇺🇸

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States

and more 200 locations
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