Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297772
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-01
Brief Title:
Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan Dec-FB4 and Fludarabine-busulfan FB4 as Conditioning Regimens for AML-MR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
A multicenter randomized controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan Dec-FB4 and Fludarabine-busulfan FB4 as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities
Detailed Description:
AML-MR is one of high-risk AML with aggressive disease progression and poor prognosis The median survival of AML-MR is only 105 months Allogeneic hematopoietic stem cell transplantation allo-HSCT is an effective post-remission therapy for high-risk acute myeloid leukemia AMLmyelodysplastic syndrome MDS Selection of an appropriate pretreatment regimen that balances the risk of relapse and reduces the risk of non-relapse mortality is a key component of successful HSCT FB4 regimen consisting of Fludarabine FLU combined with busulfan BU has become the most commonly used myeloablative preconditioning regimen for allo-HSCT in patients with AMLMDS and prospective studies have demonstrated a similar relapse rate and lower treatment-related mortality than the Bucy regimen
Decitabine is also approved for the treatment of AML and MDS as an inhibitor of DNA methyltransferase I which allows for the expression of silenced oncogenes and terminal differentiation of leukemia cells and as a single agent is superior to supportive therapy for patients with MDS In addition decitabine has been shown to attenuate GVHD by enhancing the function of regulatory T cells and in myeloid tumors several prospective single-arm and retrospective clinical studies have demonstrated that modified pretreatment regimens containing decitabine have a lower relapse rate as well as a reduction in the incidence and severity of GVHD with satisfactory survival data in allogeneic hematopoietic stem cell transplantation The investigators have not yet obtained direct evidence in high-risk patients to confirm the superiority of decitabine-containing pretreatment regimens over standard pretreatment regimens FB4 There is a lack of prospective controlled studies to clarify the efficacy and safety of decitabine-containing transplantation preconditioning in high-risk patients especially those with specific AML-MRTherefore this multicenter randomized controlled study was designed to compare the efficacy and safety of Dec-FB4 and FB4 regimens as pretreatment regimens for allogeneic HSCT in adults with AML-MR and to assess whether Dec-FB4 is superior or noninferior to FB4 in order to provide a reliable evidence-based medical basis for guiding the therapeutic choices for AML-MRMDS patients
Decitabine is also approved for the treatment of AML and MDS as an inhibitor of DNA methyltransferase I which allows for the expression of silenced oncogenes and terminal differentiation of leukemia cells and as a single agent is superior to supportive therapy for patients with MDS In addition decitabine has been shown to attenuate GVHD by enhancing the function of regulatory T cells and in myeloid tumors several prospective single-arm and retrospective clinical studies have demonstrated that modified pretreatment regimens containing decitabine have a lower relapse rate as well as a reduction in the incidence and severity of GVHD with satisfactory survival data in allogeneic hematopoietic stem cell transplantation The investigators have not yet obtained direct evidence in high-risk patients to confirm the superiority of decitabine-containing pretreatment regimens over standard pretreatment regimens FB4 There is a lack of prospective controlled studies to clarify the efficacy and safety of decitabine-containing transplantation preconditioning in high-risk patients especially those with specific AML-MRTherefore this multicenter randomized controlled study was designed to compare the efficacy and safety of Dec-FB4 and FB4 regimens as pretreatment regimens for allogeneic HSCT in adults with AML-MR and to assess whether Dec-FB4 is superior or noninferior to FB4 in order to provide a reliable evidence-based medical basis for guiding the therapeutic choices for AML-MRMDS patients
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