Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach

Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach.

Treatment of cancer, and more particularly of haematological malignancies, partly relies on chemotherapy. Most therapeutic regimens display various toxicities, one of the most common being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia can be overcome by haematological growth factors and transfusion, one of the most severe life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major limitation in chemotherapy which is responsible for the majority of treatment-related morbidity and mortality and for prolonged hospitalisation.

In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic patients. While the occurence of neutropenia and sepsis is often unpredictable and thus difficult to study in a prospective way, stem cell transplantation represents a quite convenient model to study such a question. Autologous stem cell transplantation indications in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly, after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by cytapheresis and frozen. When the patient has reached complete remission by conventional chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called "conditioning regimen"). The "conditioning regimen" targeted to have high antitumoral activity leads to a "cytokine storm" resulting in a "programmed inflammation". 36 hours after the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days, until graft becomes "functional". Thus, the timing and duration of neutropenia are very homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus, most patient will be informative regarding sepsis, and there is an easy possibility of biological sampling before" programmed inflammation" (due to conditioning regimen), after inflammation before sepsis, then during and after the sepsis. Since the patient is hospitalized, the kinetic monitoring is quite easy

Study Overview

• Status: Unknown
• Conditions: Sepsis in Neutropenic Patients
• Intervention / Treatment: Biological: blood draw

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: laure farnault; Phone Number: 04 91 38 41 53; Email: laure.farnault@ap-hm.fr
    • Principal Investigator: laure farnault

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the criteria required to be candidate in an ASCH in our service(department) (age 18 - 66 years, myélome in 1 ° in reply partial line or lymphoma or complete answer after one 2 ° line, absence of preliminary visceral failure).

Informed, willing patients and having given their agreement in writing.

Exclusion Criteria:

• Refusal of the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood samples	Biological: blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood samples	transcriptomic profile identification	3 YEARS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood samples	the observed profile in patients developing fever and sepsis in comparison with patients not developing such complications	3 YEARS
blood samples	the prediction, for each patient, a transcriptomic signature linked to a higher risk developing a sepsis.	3 YEARS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2012-A00322-41; 2012-08 (AP HM)