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Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia

NCT ID: NCT00138736

Last Updated: 2007-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-10-31

Brief Summary

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The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.

Detailed Description

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Mannan Binding Lectin (MBL) is a member of the lectin pathway of the complement system and plays an important role in the innate immune system. MBL replacement in MBL-deficient children with chemotherapy-induced neutropenia represents a new approach to lower the risk of febrile episodes, of hospital admission, of prolonged use of intravenous antibiotics and of severe infections.

The aim of the Phase II study is to find evidence for the correct prediction of plasma levels of MBL necessary for clinical effects and biological efficacy, to confirm the dosage regimen needed to reach the required MBL plasma levels, and reconfirm the safety and lack of side-effects.

Conditions

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MBL-Deficient Neutropenia

Keywords

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MBL-deficient chemotherapy neutropenia chemotherapy-induced neutropenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

MBL until the patient's absolute neutrophil count (ANC) is above 500/microL blood.

Group Type EXPERIMENTAL

Mannan Binding Lectin (MBL)

Intervention Type DRUG

Mannan Binding Lectin

Intervention Type DRUG

MBL dose at a twice weekly dose interval (3 or 4 days):

0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval

Interventions

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Mannan Binding Lectin (MBL)

Intervention Type DRUG

Mannan Binding Lectin

MBL dose at a twice weekly dose interval (3 or 4 days):

0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval

Intervention Type DRUG

Other Intervention Names

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MBL SSI

Eligibility Criteria

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Inclusion Criteria

* Children ages 0 - 12 years, during chemotherapy, and expected to become neutropenic
* MBL deficiency by genotype or phenotype (\< 100 ng/ml)
* Informed consent and assent of patient and/or legal representative

Exclusion Criteria

* Inability or unwillingness to comply with the protocol or likely inability to complete the study period
* Known allergic reactions to MBL and other human plasma products
* Participation in other investigational drug studies within the last month
* Clinically relevant abnormalities in: serum immunoglobulins IgG, IgA, IgM; blood counts; complement factors measured by AP50, CH50; urine protein and cell counts; serum creatinine and liver enzymes, as routinely determined for regular patient care.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landsteiner Foundation for Blood Transfusion

OTHER

Sponsor Role collaborator

Prothya Biosolutions

INDUSTRY

Sponsor Role lead

Principal Investigators

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T W Kuijpers, MD, PdD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Paediatric Immunology, AMC, Amsterdam, The Netherlands

H N Caron

Role: PRINCIPAL_INVESTIGATOR

Dept of Paediatric Oncology, AMC, Amsterdam, The Netherlands

Locations

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Academic Medical Centre

Amsterdam, , Netherlands

Site Status

Erasmus Medical Centre

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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KB2003.02

Identifier Type: -

Identifier Source: org_study_id