Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490562
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-19
Brief Title:
Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Clinical Trial Protocol for the Efficacy and Safety of Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Assess the cumulative incidence of severe III-IV aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI Evaluate the overall survival rate OS non recurrent mortality rate NRM and recurrence rate CIR of two groups of patients The complete response rate CR and partial response rate PR of patients with morphologicalextramedullary recurrence as well as the complete response rate and MRD response rate of patients with molecular recurrence The incidence of adverse events such as infection hemorrhagic cystitis and cardiac events in two groups
Detailed Description:
Assess the cumulative incidence of severe III-IV aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI Evaluate the overall survival rate OS non recurrent mortality rate NRM and recurrence rate CIR of two groups of patients The complete response rate CR and partial response rate PR of patients with morphologicalextramedullary recurrence as well as the complete response rate and MRD response rate of patients with molecular recurrence The incidence of adverse events such as infection hemorrhagic cystitis and cardiac events in two groups
Efficacy Evaluation Follow up observation of the difference in efficacy and safety between two groups in preventing severe III-IV aGVHD
Primary Exploratory Endpoint Assess the cumulative incidence of severe III-IV aGVHD after low-dose cyclophosphamide or CNI is used after gDLI
Secondary Exploratory Endpoints
1 1-year overall survival rate OS
2 1-year recurrence rate CIR
3 1-year non recurrent mortality rate NRM
4 The complete response rate CR and partial response rate PR of patients with morphologicalextramedullary recurrence as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease MRD
5 The incidence of adverse events such as infection hemorrhagic cystitis and cardiac events in two groups
Efficacy Evaluation Follow up observation of the difference in efficacy and safety between two groups in preventing severe III-IV aGVHD
Primary Exploratory Endpoint Assess the cumulative incidence of severe III-IV aGVHD after low-dose cyclophosphamide or CNI is used after gDLI
Secondary Exploratory Endpoints
1 1-year overall survival rate OS
2 1-year recurrence rate CIR
3 1-year non recurrent mortality rate NRM
4 The complete response rate CR and partial response rate PR of patients with morphologicalextramedullary recurrence as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease MRD
5 The incidence of adverse events such as infection hemorrhagic cystitis and cardiac events in two groups
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