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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Liposomal cytarabine
Intrathecal triple
Sponsored by
Nordic Society for Pediatric Hematology and Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Leukemia, Central nervous system, Neurotoxicity, Liposomal cytarabine, Children, Acute lymphoblastic leukemia, Childhood acute lymphoblastic leukemia, Intrathecal, Efficacy, Safety

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatrics, Rigshospitalet
  • Helsinki University Hospital
  • University of Reykjavik, Iceland
  • University Hospital of Trondheim, Norway
  • Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal cytarabine

Intrathecal triple

Arm 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

Intrathecal methotrexate, cytarabine and prednisolone

Outcomes

Primary Outcome Measures

Number of leukemia relapses in the central nervous system

Secondary Outcome Measures

Neurological toxicity

Full Information

First Posted
October 7, 2009
Last Updated
October 6, 2012
Sponsor
Nordic Society for Pediatric Hematology and Oncology
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00991744
Brief Title
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Suspended
Why Stopped
Sterility problems in DepoCyte production
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordic Society for Pediatric Hematology and Oncology
Collaborators
Oulu University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Leukemia, Central nervous system, Neurotoxicity, Liposomal cytarabine, Children, Acute lymphoblastic leukemia, Childhood acute lymphoblastic leukemia, Intrathecal, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal cytarabine
Arm Type
Experimental
Arm 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
Arm Title
Intrathecal triple
Arm Type
Active Comparator
Arm Description
Intrathecal methotrexate, cytarabine and prednisolone
Intervention Type
Drug
Intervention Name(s)
Liposomal cytarabine
Other Intervention Name(s)
Cytarbine, Ara-C, Cytosar-U, Cytosine arabinoside, Precortalon, Di-Adreson F
Intervention Description
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Intervention Type
Drug
Intervention Name(s)
Intrathecal triple
Other Intervention Name(s)
DepoCyte, DepoCyt, Precortalon, Di-Adreson-F, Cytarabine, Ara-C, Cytosar-U, Cytosine arabinoside
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of leukemia relapses in the central nervous system
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Neurological toxicity
Time Frame
6 months after cessation of leukemia therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arja Harila-Saari, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
University of Reykjavik, Iceland
City
Reykjavik
Country
Iceland
Facility Name
University Hospital of Trondheim, Norway
City
Trondheim
Country
Norway
Facility Name
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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