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Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)

NCT00991744 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-10-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liposomal cytarabine

Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL

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

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER

  • Nordic Society for Pediatric Hematology and Oncology

    lead OTHER

Principal Investigators

  • Arja Harila-Saari, MD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00991744 on ClinicalTrials.gov