drugset / Trial / NCT00991744
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
Phase 3
Suspended
100 enrolled
Nordic Society for Pediatric Hematology and Oncology
Oulu University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
* Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients. * Both acute and long-term toxicity are equal in both treatment arms.
Timeline
- Start
- 2009-01
- Primary completion
- 2018-12
- Completion
- 2018-12
Outcome
Outcome not reported
Stopped: “Sterility problems in DepoCyte production”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 20 mg | Intrathecal |
| Subject | Cytarabine | Small molecule | 25 mg | Intrathecal |
| Subject | Cytarabine | Small molecule | 30 mg | Intrathecal |
| Subject | Cytarabine | Small molecule | 50 mg | Intrathecal |
| Comparator | Methotrexate | Small molecule | 8 mg | Intrathecal |
| Comparator | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Prednisolone | Other / unclassified | 12.5 mg | Intrathecal |
| Background | Prednisolone | Other / unclassified | 20 mg | Intrathecal |