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

October 6, 2012 updated by: Arja Harila-Saari, Nordic Society for Pediatric Hematology and Oncology

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

  • 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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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:

  1. 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.
  2. To evaluate acute and long-term toxicity in both treatment arms.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Pediatrics, Rigshospitalet
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
  • Iceland
      • Reykjavik, Iceland
        • University of Reykjavik, Iceland
  • Norway
      • Trondheim, Norway
        • University Hospital of Trondheim, Norway
  • Sweden
      • Gothenburg, Sweden
        • Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • Ara-C
  • Cytosar-U
  • Cytosine arabinoside
  • Cytarbine
  • Precortalon
  • Di-Adreson F
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
Other Names:
  • Ara-C
  • Cytosar-U
  • Cytosine arabinoside
  • Cytarabine
  • Di-Adreson-F
  • DepoCyt
  • DepoCyte
  • Precortalon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of leukemia relapses in the central nervous system
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurological toxicity
Time Frame: 6 months after cessation of leukemia therapy
6 months after cessation of leukemia therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society for Pediatric Hematology and Oncology

Collaborators

Oulu University Hospital

Investigators

  • Principal Investigator: Arja Harila-Saari, MD, Oulu University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 6, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOPHOALL2008-DepoCyte

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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