Clinical Trial: NCT04817761
SPARK-ALL: Calaspargase Pegol in Adults With ALL
Status:
TERMINATEDPhase:
Phase 2| Lead Sponsor: | Institut de Recherches Internationales Servier |
| Information Provided By: | Servier |
| Last Update Posted: | 2026-02-18 |
Study Overview
Brief 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.
Official Title
SPARK-ALL: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.
Conditions
Acute Lymphoblastic Leukemia
Intervention / Treatment
- Drug: Calaspargase pegol (S95015)
Other Study ID Numbers
- CL2-95015-001
Start Date (Actual)
2021-07-07
Primary Completion Date (Actual)
2025-03-21
Study Completion Date (Actual)
2025-03-21
Enrollment (Actual)
42
Study Type
Interventional
Phase
Phase 2, Phase 3
| Lead Sponsor: | Institut de Recherches Internationales Servier |
| Information Provided By: | Servier |
| Last Update Posted: | 2026-02-18 |
Study Overview
Brief 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.
Official Title
SPARK-ALL: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.
Conditions
Acute Lymphoblastic Leukemia
Intervention / Treatment
- Drug: Calaspargase pegol (S95015)
Other Study ID Numbers
- CL2-95015-001
Start Date (Actual)
2021-07-07
Primary Completion Date (Actual)
2025-03-21
Study Completion Date (Actual)
2025-03-21
Enrollment (Actual)
42
Study Type
Interventional
Phase
Phase 2, Phase 3