NCT00991744

Brief 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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
5 countries

5 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

9.9 years

First QC Date

October 7, 2009

Last Update Submit

October 6, 2012

Conditions

Acute Lymphoblastic Leukemia

Keywords

LeukemiaCentral nervous systemNeurotoxicityLiposomal cytarabineChildrenAcute lymphoblastic leukemiaChildhood acute lymphoblastic leukemiaIntrathecalEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • Number of leukemia relapses in the central nervous system

    5 years

Secondary Outcomes (1)

  • Neurological toxicity

    6 months after cessation of leukemia therapy

Study Arms (2)

Liposomal cytarabine

EXPERIMENTAL

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 triple

ACTIVE COMPARATOR

Intrathecal methotrexate, cytarabine and prednisolone

Drug: Intrathecal triple

Interventions

Liposomal cytarabineDRUG

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

Also known as: Cytarbine, Ara-C, Cytosar-U, Cytosine arabinoside, Precortalon, Di-Adreson F
Liposomal cytarabine
Intrathecal tripleDRUG

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

Also known as: DepoCyte, DepoCyt, Precortalon, Di-Adreson-F, Cytarabine, Ara-C, Cytosar-U, Cytosine arabinoside
Intrathecal triple

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High risk acute lymphoblastic leukemia
  • Not eligible for bone marrow transplantation
  • Age 1-18
  • Written informed consent has been obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Pediatrics, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

University of Reykjavik, Iceland

Reykjavik, Iceland

Location

University Hospital of Trondheim, Norway

Trondheim, Norway

Location

Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemiaNeurotoxicity Syndromes

Interventions

CytarabineMethylprednisolonePrednisolone

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Arja Harila-Saari, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

FI(1)NO(1)IC(1)SE(1)DK(1)