Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled. IND withdrawn.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever, Sweats, and Hot Flashes | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human mannose-binding lectin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Toxicity
- measure
- Pharmacokinetics
- measure
- Efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier method contraception during and for ≥ 30 days after completion of study treatment * AST and ALT ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Creatinine clearance \> 60 mL/min OR creatinine based on age as follows: * No more than 0.8 mg/dL (for patients 5 years of age and under) * No more than 1.0 mg/dL (for patients 6-9 years of age) * No more than 1.2 mg/dL (for patients 10-12 years of age) * No more than 1.4 mg/dL (for patients over 13 years of age \[female\]) * No more than 1.5 mg/dL (for patients 13-15 years of age \[male\]) * No more than 1.7 mg/dL (for patients of 16 years of age \[male\]) * No poor venous access that would preclude IV drug delivery or multiple blood draws * Patients on hemodialysis must be able to tolerate IV fluid on non-dialysis days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 30 days since prior investigational agents * Investigational use of an FDA-approved drug allowed * No concurrent preparative regimen for a bone marrow or hematopoietic stem cell transplantation * No concurrent participation in another clinical trial with an investigational agent
References
Publications (0)
Data not yet available