Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532552
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Comparison of VA Venetoclax Azacitidine VACl VA Cladribine VACh VA Chidamide and Alternating VAClVACh in Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of VA Venetoclax Azacitidine VACl VA Cladribine VACh VA Chidamide and Alternating VAClVACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining A Prospective Multi-center Randomized Controlled Phase II Study
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 prospective multi-center randomized controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl VenetoclaxAzacitidineCladribine alternating with VACh VenetoclaxAzacitidineChidamide VACl VACh and VA in newly diagnosed adult acute myeloid leukemia AML patients ineligible for intensive therapy or declining Cladribine is a purine analogue widely used in hematologic malignancies The monocytic leukemia stem cell is selective sensitivity to Cladribine Chidamide a newly designed selective histone deacetylase inhibitor could down regulate myeloid cell leukaemia 1 MCL1 expression in Venetoclax resistant AML cells Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms which can eradicate leukemia stem cells and prevent the occurrence of drug resistance
Detailed Description:
AML is a clonal myelopoietic stem cell disorder characterized by the accumulation of neoplastic cells in the bone marrow and in the peripheral circulation The median age of AML patients is 68 years Although intensive chemotherapy and allogeneic stem cell transplant allo-HSCT are standard approaches for newly diagnosed patients they are associated with higher rates of treatment related complications and inferior outcomes in older patients Venetoclax a newly orally available and selective B cell lymphoma-2 BCL2 inhibitor Venetoclax in combination with hypomethylation agents or cytarabine has been approved by the Food and Drug Administration FDA for the treatment of patients with newly diagnosed AML unfit for intensive chemotherapy However the emergence of resistance to Venetoclax based combinations has become an important clinical dilemma Resistance to Venetoclax can be acquired through the up regulation of anti-apoptotic proteins such as myeloid cell leukaemia 1 MCL1 Chidamide a newly designed selective histone deacetylase inhibitor Chidamide could down Bregulate MCL1 expression in Venetoclax resistant AML cells Our experience showed that the ChidamideVA could improve the condition of RR AML patients who are resistant to VA Cladribine is a purine analogue widely used in hematologic malignancies It was demonstrated that addition of Cladribine to the VA regimen increases eradication of primary AML containing monocytic leukemia stem cell activity in both in vitro and in vivo preclinical models Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms which can eradicate leukemia stem cells and prevent the occurrence of drug resistance thereby increasing response rate prolonging patient survival reducing recurrence and improving prognosis without increasing treatment-related complications Therefore this prospective multi-center randomized controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl VenetoclaxAzacitidineCladribine alternating with VACh VenetoclaxAzacitidineChidamide VACl VACh and VA in newly diagnosed adult AML patients ineligible for intensive therapy or declining
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