Clinical trial · Interventional
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sterility problems in DepoCyte production
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrathecal triple | Drug | — | UNRESOLVED |
| Liposomal cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liposomal cytarabine
- description
- Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL
- interventionNames
- Drug: Liposomal cytarabine
- type
- ACTIVE_COMPARATOR
- label
- Intrathecal triple
- description
- Intrathecal methotrexate, cytarabine and prednisolone
- interventionNames
- Drug: Intrathecal triple
Primary outcomes (1)
- measure
- Number of leukemia relapses in the central nervous system
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * High risk acute lymphoblastic leukemia * Not eligible for bone marrow transplantation * Age 1-18 * Written informed consent has been obtained Exclusion Criteria: * Persistent NCI grade 3-4 neurotoxicity from previous treatments * Bilineage ALL * Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia) * Previous cancer * Known intolerance to NOPHO ALL 2008 anticancer agents * Sexually active females will use safe contraceptives * Previous treatment with intrathecal liposomal cytarabine
References
Publications (0)
Data not yet available