Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01693952
Status:
UNKNOWN
Last Update Posted:
2014-09-01
First Post:
2012-05-21
Brief Title:
Sepsis in Neutropenic Patients Autologous Stem Cell Transplantation as Model a Transcriptomic Approach
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Sepsis in Neutropenic Patients Autologous Stem Cell Transplantation as Model a Transcriptomic Approach
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-08 | OTHER | AP HM | None |