drugset / Trial / NCT04817761
SPARK-ALL: Calaspargase Pegol in Adults With ALL
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.
Timeline
- Start
- 2021-07-07
- Primary completion
- 2025-03-21
- Completion
- 2025-03-21
Publications
- Background Stock W, Park JH, Emadi A, Abdul-Hay M, Cassaday RD, Pullarkat VA, Webster J, Pandya SS, Mogul MJ, Shvenke Y, Zhu JJ, Tessier A, DeAngelo DJ. Safety and Pharmacokinetics of Calaspargase Pegol in Adults with Newly Diagnosed Philadelphia-Negative ALL: A Phase 2/3 Study. Blood. 2021 Nov 23;138(Supplement 1):4406. doi: https://doi.org/10.1182/blood-2021-149463
- Aldoss I, Ali A, Cassaday RD, Curran EK, Luskin MR, Maese LD, Orgel E, Douer D. Optimizing Asparaginase Treatment for Adolescent and Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia: US Consensus Panel Recommendations. Am J Hematol. 2026 Jan;101(1):41-55. doi: 10.1002/ajh.70103. Epub 2025 Oct 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calaspargase Pegol | Protein / enzyme biologic | 1000 unknown | Intravenous |
| Subject | Calaspargase Pegol | Protein / enzyme biologic | 1500 unknown | Intravenous |
| Subject | Calaspargase Pegol | Protein / enzyme biologic | 1750 unknown | Intravenous |
| Subject | Calaspargase Pegol | Protein / enzyme biologic | 2000 unknown | Intravenous |