Acute Leukemia Clinical Trial
— MBL INFFONGOfficial title:
Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)
NCT number | NCT02823132 |
Other study ID # | Goyer APJ 2013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | June 29, 2016 |
Last updated | July 5, 2016 |
The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.
Status | Completed |
Enrollment | 134 |
Est. completion date | |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria : - persons who have provided written consent - Patients with national health insurance cover - Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN < 500 / mm3) lasting more than 10 days. - Patients with malignant hemopathy who have received an autologous bone marrow graft - Patients with severe idiopathic medullar aplasia (PN < 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants) Exclusion Criteria: - Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study). - Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days). - Patients whose neutropenia, retrospectively assessed, lasted less than 10 days. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia | 1st day of the period of aplasia | No | |
Secondary | Serum levels of MBL during an episode of aplasia for both groups of patients studied | Every day except Saturday and Sunday for roughly 3 weeks | No |
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