Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256627
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
The Maintenance Treatment of ITIVA in AML Patients
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Multicenter Single Arm Clinical Study on the Efficacy and Safety of the ITIVA Protocol in Patients With Complete Remission of AML at Initial Diagnosis
Status:
RECRUITING
Status Verified Date:
2023-08
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:
We apply for this clinical study to evaluate the efficacy of combined recombinant human interference- α- 1b interleukin-2 and thalidomide regimen in obtaining MRD positive AML patients in CRas well as the efficacy of the Venentoclax and azacitidine regimen and the combined recombinant human interference- α- 1b interleukin-2 and thalidomide regimen in alternately maintaining the treatment of MRD negative AML patients The study included two cohorts The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy They were randomly given two cycles of recombinant human interference- α- 1b interleukin-2 and thalidomide or VA regimen treatment and the MRD conversion rates of the two groups were analyzed In the second cohort after induction chemotherapy and consolidation chemotherapy AML patients with CR or CRi and negative MRD were obtained and were given recombinant human interference- α- 1b interleukin-2 and thalidomide Venentoclax and Azacitidine triple alternative maintenance treatment to analyze the impact of maintenance treatment scheme on long-term survival of aml patients
Detailed Description:
None
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