MedPath

Calaspargase pegol

Generic Name
Calaspargase pegol
Brand Names
Asparlas
Drug Type
Biotech
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)

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

Phase 2
Not yet recruiting
Conditions
T-cell Acute Lymphoblastic Leukemia
T-Cell Lymphoblastic Lymphoma
Interventions
First Posted Date
2024-08-19
Last Posted Date
2025-04-09
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT06561074
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

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
Recruiting
Conditions
B Acute Lymphoblastic Leukemia
Acute Leukemia of Ambiguous Lineage
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: FDG-Positron Emission Tomography
Procedure: Lumbar Puncture
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
First Posted Date
2024-03-19
Last Posted Date
2025-05-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
153
Registration Number
NCT06317662
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

🇺🇸

Albany Medical Center, Albany, New York, United States

🇺🇸

University of Virginia Cancer Center, Charlottesville, Virginia, United States

and more 5 locations

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
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Lumbar Puncture
Procedure: Multigated Acquisition Scan
Biological: Navitoclax
Procedure: Positron Emission Tomography
Procedure: X-Ray Imaging
First Posted Date
2024-01-18
Last Posted Date
2024-05-17
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT06210750

A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Phase 2
Recruiting
Conditions
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
Recurrent Mixed Phenotype Acute Leukemia
Recurrent Acute Leukemia of Ambiguous Lineage
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged
Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged
Recurrent Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage
Refractory Acute Leukemia of Ambiguous Lineage
Refractory Acute Lymphoblastic Leukemia
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Echocardiography
Procedure: Lumbar Puncture
Procedure: Multigated Acquisition Scan
First Posted Date
2023-03-09
Last Posted Date
2025-03-19
Lead Sponsor
Children's Oncology Group
Target Recruit Count
78
Registration Number
NCT05761171
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

🇺🇸

Kaiser Permanente Downey Medical Center, Downey, California, United States

and more 66 locations

Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

Phase 3
Recruiting
Conditions
Mixed Phenotype Acute Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Lymphoblastic Lymphoma
B Acute Lymphoblastic Leukemia
T Acute Lymphoblastic Leukemia
Interventions
Procedure: Biospecimen Collection
Dietary Supplement: Levocarnitine
Other: Quality-of-Life Assessment
First Posted Date
2022-11-02
Last Posted Date
2025-03-19
Lead Sponsor
Children's Oncology Group
Target Recruit Count
440
Registration Number
NCT05602194
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

🇺🇸

Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 208 locations

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Phase 1
Recruiting
Conditions
Acute Lymphoblastic Leukemia
Interventions
Drug: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)
First Posted Date
2022-10-14
Last Posted Date
2025-05-07
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
20
Registration Number
NCT05581030
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Phase 1
Recruiting
Conditions
Myelodysplastic Syndromes, Secondary
Myelodysplastic Syndromes, Previously Treated
Treatment-Related Acute Myeloid Leukemia
Therapy-Related Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia With Failed Remission
Myelodysplastic Syndromes, de Novo
Lymphoblastic Lymphoma, in Relapse
Acute Leukemia of Ambiguous Lineage in Relapse
Lymphoblastic Lymphoma, Refractory
Acute Leukemia of Ambiguous Lineage
Interventions
First Posted Date
2022-03-23
Last Posted Date
2025-02-17
Lead Sponsor
Andrew E. Place, MD
Target Recruit Count
92
Registration Number
NCT05292664
Locations
🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

University of California San Francisco-Benioff Children's Hospital, San Francisco, California, United States

🇺🇸

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

and more 1 locations

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

First Posted Date
2022-01-14
Last Posted Date
2024-11-26
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
35
Registration Number
NCT05192889
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

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