Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536154
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2022-09-07
Brief Title:
EtoposideCytarabinePEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
Sponsor:
The Affiliated Peoples Hospital of Ningbo University
Organization:
The Affiliated Peoples Hospital of Ningbo University
Study Overview
Official Title:
Prospective Single-arm Multicenter Exploratory Clinical Study of the Combination of Etoposide Cytarabine and PEG-rhG-CSF EAP Regimen as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
This is a single-arm multicenter exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide cytarabine and PEG-rhG-CSF EAP regimen as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma All eligible patients will receive EAP regimen treatment then the number of CD34 cells and white blood cells will be monitoring When the collection standard is met hematopoietic stem cell collection will be started
Detailed Description:
In patients older than 65 years or with creatinine 25 mgdL but with an endogenous creatinine clearance 50 the dose of etoposide and Ara-C should be reduced by one-quarter to one-third
Routinely blood analyses and peripheral blood CD34 cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection If the WBC count is 10109L 5μgkgd of G-CSF should be injected subcutaneously until the end of HSC collection
Leukapheresis can be performed when the white blood cell counts recover WBC count was4109L following chemotherapy and the CD34 cell count was20μL Leukapheresis started if the peripheral blood CD34 counts plateaued at 5 cellsμL and 20 cellsμL after recovery of white blood cell counts following chemotherapy the clinician decided whether to add plerixafor based on the specific situation of the patient Leukapheresis should be abandoned if the peak circulating CD34 cells were 5μL up to 20 days after chemotherapy CD34 cells were determined by multi-parameter flow cytometry and a dual-platform approach Two blood cell separators were used at the study sites Spectra-Optia Apheresis system Terumo BCT Lake-wood CO USA COMTEC Fresenius Kabi During each leukapheresis 25 times the patients blood volume 25 had to be processed within 5 h
Routinely blood analyses and peripheral blood CD34 cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection If the WBC count is 10109L 5μgkgd of G-CSF should be injected subcutaneously until the end of HSC collection
Leukapheresis can be performed when the white blood cell counts recover WBC count was4109L following chemotherapy and the CD34 cell count was20μL Leukapheresis started if the peripheral blood CD34 counts plateaued at 5 cellsμL and 20 cellsμL after recovery of white blood cell counts following chemotherapy the clinician decided whether to add plerixafor based on the specific situation of the patient Leukapheresis should be abandoned if the peak circulating CD34 cells were 5μL up to 20 days after chemotherapy CD34 cells were determined by multi-parameter flow cytometry and a dual-platform approach Two blood cell separators were used at the study sites Spectra-Optia Apheresis system Terumo BCT Lake-wood CO USA COMTEC Fresenius Kabi During each leukapheresis 25 times the patients blood volume 25 had to be processed within 5 h
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None