Biomarker To Evaluate Protein Profiles of Neutropenic Fever/Infection With Acute or Chronic Leukemias

Not Recruiting

Trial ID: NCT01144793

Purpose

The purpose of this study is to measure, in pilot/observational study, panels of circulating proteins in real time at the onset of neutropenic fever/infection in patients with acute or chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate preliminary trend results in panels of circulating proteins longitudinally during the period of neutropenia and to correlate those values to clinical/laboratory data and patient outcomes.

Official Title

A Pilot/Observational Study Using a Biomarker Monitoring System to Evaluate Protein Profiles of Neutropenic Fever/Infection in Patients With Acute or Chronic Leukemias Undergoing Chemotherapy or Other Biologic Treatment

Stanford Investigator(s)

Jason Gotlib

Professor of Medicine (Hematology)

Eligibility


Inclusion Criteria:- Age >= 18

   - Pre-admission (ATU, ITA) or inpatient status

   - absolute neutrophil count (ANC) <= 1500/mm^3

   - Patients with acute myeloid or lymphoid leukemia who:

      - are admitted with newly diagnosed disease and have not yet received induction
      chemotherapy

      - are admitted with neutropenic fever after receiving post-remission chemotherapy
      or are admitted for post-remission chemotherapy

   - Patients with chronic myeloid leukemia or a chronic lymphoid leukemia/disorder who
   have received chemotherapy or other disease-specific treatment in the last 30 days
   where the ANC of <=1500/mm3 is considered by the treating physician to be at least
   possibly treatment-related

   - An intravenous line or catheter (Hickman, port, portacath, or peripherally inserted
   central venous catheter [PICC] line) must be in place at the time of protocol
   participation/study start, but will not be inserted solely for the purposes of the
   study.

   - Whenever possible, patients will be consented and blood monitoring will be initiated
   before the first dose of antibiotic, but if not possible, at no time will standard of
   care measures will be delayed or interrupted for the purposes of study enrollment.

   - Patients must be able to understand the nature of the study and give written informed
   consent.

There are no exclusion criteria. Anyone who does not meet inclusion criteria will be
excluded.

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea Linder
6507254047

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