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Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia

A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients With Fever and Neutropenia

NCT00886496•Enzon Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer. PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human mannose-binding lectin in treating young patients with MBL deficiency and fever and neutropenia.

Detailed Description

OBJECTIVES: Primary * Determine the safety and tolerability of recombinant human mannose-binding lectin (MBL) in pediatric patients with MBL deficiency and fever and neutropenia who are undergoing cytotoxic chemotherapy for hematological/oncological disease. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine the pharmacodynamic effect of this drug in these patients. * Determine nonspecific activation of complement by in vivo determination of C3d complement activation in patients treated with this drug. * Determine the ex-vivo activity of recombinant MBL in opsonization capacity of patients' sera to yeast and bacteria. * Determine immunogenicity of this drug in these patients. * Determine the incidence and duration of fever and breakthrough infections in patients treated with this drug. OUTLINE: This is a non-randomized, multicenter, open-label, prospective, cohort study. Patients are assigned to 1 of 2 treatment groups. * Group I: Patients receive low-dose recombinant human mannose-binding lectin (MBL) IV over 1 hour within 72 hours of onset of fever and neutropenia. * Group II: Patients receive high-dose recombinant human MBL IV over 1 hour within 72 hours of onset of fever and neutropenia. Patients undergo blood collection periodically during study for pharmacokinetic, pharmacodynamic, MBL immunogenicity, and opsonization/phagocytosis studies. After completion of study treatment, patients are followed for 30 days. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Undergoing cytologic chemotherapy for hematological/oncological disease
•Must meet all of the following criteria:
•* Documented mannose-binding lectin (MBL) levels \< 300 ng/mm³ within the past week
•* Fever (oral temperature \> 100.4° F)
•* Neutropenia, defined as absolute neutrophil count ≤ 1,000/mm³ with the anticipation that the counts will fall below 500/mm\^3
•* Receiving broad spectrum antibiotic therapy for fever and neutropenia
•PATIENT CHARACTERISTICS:
•No serious illness, in the opinion of the principal investigator, that would preclude study compliance
•No known allergic reactions to mannose-binding lectin or other human plasma products
+20 more criteria

Locations (3)

Children's Hospital of Orange County

Orange, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 1, 2006

Completion Date

April 1, 2011

Last Updated

June 20, 2012

Conditions

Fever, Sweats, and Hot FlashesInfectionLeukemiaLymphomaMyelodysplastic SyndromesNeutropeniaUnspecified Childhood Solid Tumor, Protocol Specific

Interventions

recombinant human mannose-binding lectin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia

Inclusion Criteria

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