Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04415008
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2020-05-31
Brief Title:
Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
Sponsor:
wang jianxiang
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Prospective Multicenter Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2023-10
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:
Acute myeloid leukemia is a heterogenous hematological malignancy characterized by different cytogenetic or molecular features CEBPA double mutation acute myeloid leukemia CEBPAdm AMLhas favourite prognosis especially in younger adult patients But cumulative incidence of relapse of this group patients is still high so the treatment options need to be optimized urgentlyHADhomoharringtonineHHTcytarabinedaunorubicin with intermediate dose cytarabine improved the survival of AML especially in patients with CEBPA double mutation
Detailed Description:
In this phase 2 study 40 patients will be enrolled and treated with HAD induction regimen High dose cytarabine will be given after complete remission achieved The primary endpoint was event-free and relapse-free survival Genetic mutations and measurable residual disease MRD will be detected at diagnosis and after chemotherapy The risk stratification according to genetic mutations and MRD will also be explored
induction chemotherapyHHT 2mgm2dday 1-7 cytarabine 100mgm2d day1-41gm2 q12h day5-7 DNR 40mgm2dday 1-3 re-induction chemotherapyIDA 10mgm2day 1-3 cytarabine 100mgm2day 1-7 CTX 350mgm2day 2day 5 consolidation chemotherapy high dose cytarabine 3gm2Q12hday1-3for three cycles
induction chemotherapyHHT 2mgm2dday 1-7 cytarabine 100mgm2d day1-41gm2 q12h day5-7 DNR 40mgm2dday 1-3 re-induction chemotherapyIDA 10mgm2day 1-3 cytarabine 100mgm2day 1-7 CTX 350mgm2day 2day 5 consolidation chemotherapy high dose cytarabine 3gm2Q12hday1-3for three cycles
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