Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520163
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide Cytarabine and PEG-rhG-CSF Combination Therapy vs Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study utilizes a prospective multicenter randomized two-arm design to evaluate the efficacy and safety of the etoposide cytarabine and pegylated recombinant human granulocyte colony-stimulating factor PEG-rhG-CSF combination therapy EAP regimen in mobilizing hematopoietic stem cells in patients with non-Hodgkins lymphoma NHL A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 21 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection CD34 cells 5106kg
Detailed Description:
Based on strict inclusion and exclusion criteria a total of 99 non-Hodgkins lymphoma patients from 16 hospitals will be selected Eligible subjects will be randomly assigned in a 21 ratio to either the experimental group or the control group The experimental group will receive the EAP regimen which combines etoposide cytarabine and pegylated recombinant human granulocyte colony-stimulating factor PEG-rhG-CSF while the control group will receive disease-specific chemotherapy mobilization regimens such as the CHOP and Hyper-CVAD Subsequently the number of CD34 cells will be monitored The study will evaluate the proportion of patients achieving the ideal collection value after a single collection CD34 cells 5106kg the proportion of patients achieving the target collection value cumulatively the total amount of CD34 cells collected and the average number of collections hematological and non-hematological adverse reactions and the proportion of patients receiving plerixafor
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