Hemostasis During Asparaginase Treatment in Acute Lymphob... | NCT01094392

Studies
Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

NCT01094392

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Jan 13, 2021Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 10, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

Mar 17, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.

The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.

Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of the coagulation parameters	The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.	December 2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

Exclusion Criteria:

No allergic reactions to PEG-asparaginase

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008.

Written informed consent has been obtained

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgitte K Albertsen, Ph.D. M.D.	Department of Pediatrics, Skejby Hospital, Aarhus, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg Hospital		Aalborg		9000	Denmark
Department of Pediatrics, Skejby Hospital

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D013927	Thrombosis

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
treatment every 6th week during 6 months
treatment every 2nd week during 6 months