Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643962
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Venetoclax Combined With Intensive Therapy for Acute Myeloid Leukemia Patients With Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment With Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Non-APL and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia AML except acute promyelocytic leukemia non-APL and exhibiting lower early peripheral blast clearance rate EPBCR after standard Intensive Induction therapy 37 regimen
Detailed Description:
This is a single-center prospective cohort study for the intensifying treatment with venetoclax on the standard 37 regimen in newly diagnosed AML non-APL participants who have lower EPBCR based on 15log on day 4 of the 37 regimen
The key eligible criteria are newly diagnosed and treatment-naïve AML non-APL according to the WHO 2022 criteria Participants are between 18 and 70 years old and fit for intensive chemotherapy A leukemia-associated immunophenotype LAIP defined by multiparameter flow cytometry MFC according to the 2022 ELN recommendation 2022 ELN is necessary for enrollment in this trial
All eligible participants receive the 37 regimen Pretreatment with hydroxyurea is permitted to manage leukocytosis
LAIP cells are enumerated on EDTA-anticoagulated peripheral blood collected before chemotherapy on days 1 and 4 of the first induction cycle each cycle is 28 days At least 100 circulating LAIP cells per microliter on day 1 are required as inclusion criteria to ensure optimal sensitivity The EPBCR is calculated on day 4 of the first induction regimen as a ratio converted to a logarithmic scale between the absolute peripheral blood LAIP cell count on day 1 baseline and day 4 A cut-off of 15 log is decisional to assign participants to treatment modalities Participants with EPBCR15 log EPBCRhigh complete the 37 regimen and are managed according to standard clinical practice Participants with EPBCR15 log EPBCRlow receive intensified treatment with venetoclax orally along with the standard 37 regimen on days 5-14 A venetoclax dose ramp-up schedule is required in the first induction therapy
After two cycles of induction therapy participants who fail to achieve composite complete remission CRCRi CRc may receive an alternative regimen per their physicians decision
After CRCRi is achieved participants proceed with consolidation therapy or allo-HSCT based on their 2022 ELN risk categories Participants with favorable risk should go through four cycles each cycle is 28 days of consolidation therapy those with adverse risk should go through allogeneic hematopoietic stem cell transplantation allo-HSCT after two cycles of consolidation therapy and those with intermediate risk can receive allo-HSCT after two cycles of consolidation therapy if suitable donors are available or continue with four cycles of consolidation therapy Participants receive four cycles of consolidation regimen of intermediate-dose cytarabine for age 60 years old or high-dose cytarabine for age 60 years old The consolidation therapy will be combined with venetoclax in the EPBCRlow cohort and not in the EPBCRhigh cohort
After consolidation participants will receive maintenance therapy per their physicians decision and be observed
The key eligible criteria are newly diagnosed and treatment-naïve AML non-APL according to the WHO 2022 criteria Participants are between 18 and 70 years old and fit for intensive chemotherapy A leukemia-associated immunophenotype LAIP defined by multiparameter flow cytometry MFC according to the 2022 ELN recommendation 2022 ELN is necessary for enrollment in this trial
All eligible participants receive the 37 regimen Pretreatment with hydroxyurea is permitted to manage leukocytosis
LAIP cells are enumerated on EDTA-anticoagulated peripheral blood collected before chemotherapy on days 1 and 4 of the first induction cycle each cycle is 28 days At least 100 circulating LAIP cells per microliter on day 1 are required as inclusion criteria to ensure optimal sensitivity The EPBCR is calculated on day 4 of the first induction regimen as a ratio converted to a logarithmic scale between the absolute peripheral blood LAIP cell count on day 1 baseline and day 4 A cut-off of 15 log is decisional to assign participants to treatment modalities Participants with EPBCR15 log EPBCRhigh complete the 37 regimen and are managed according to standard clinical practice Participants with EPBCR15 log EPBCRlow receive intensified treatment with venetoclax orally along with the standard 37 regimen on days 5-14 A venetoclax dose ramp-up schedule is required in the first induction therapy
After two cycles of induction therapy participants who fail to achieve composite complete remission CRCRi CRc may receive an alternative regimen per their physicians decision
After CRCRi is achieved participants proceed with consolidation therapy or allo-HSCT based on their 2022 ELN risk categories Participants with favorable risk should go through four cycles each cycle is 28 days of consolidation therapy those with adverse risk should go through allogeneic hematopoietic stem cell transplantation allo-HSCT after two cycles of consolidation therapy and those with intermediate risk can receive allo-HSCT after two cycles of consolidation therapy if suitable donors are available or continue with four cycles of consolidation therapy Participants receive four cycles of consolidation regimen of intermediate-dose cytarabine for age 60 years old or high-dose cytarabine for age 60 years old The consolidation therapy will be combined with venetoclax in the EPBCRlow cohort and not in the EPBCRhigh cohort
After consolidation participants will receive maintenance therapy per their physicians decision and be observed
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