Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00991744|
Recruitment Status : Suspended (Sterility problems in DepoCyte production)
First Posted : October 8, 2009
Last Update Posted : October 10, 2012
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Liposomal cytarabine Drug: Intrathecal triple||Phase 3|
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
- To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
- To evaluate acute and long-term toxicity in both treatment arms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Liposomal cytarabine
Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL
Drug: Liposomal cytarabine
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Active Comparator: Intrathecal triple
Intrathecal methotrexate, cytarabine and prednisolone
Drug: Intrathecal triple
Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol
- Number of leukemia relapses in the central nervous system [ Time Frame: 5 years ]
- Neurological toxicity [ Time Frame: 6 months after cessation of leukemia therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991744
|Department of Pediatrics, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Helsinki University Hospital|
|University of Reykjavik, Iceland|
|University Hospital of Trondheim, Norway|
|Department of Pediatrics, Drottning Sylvias Pediatric Hospital|
|Principal Investigator:||Arja Harila-Saari, MD||Oulu University Hospital|