Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03507842
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2018-04-04
Brief Title:
A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ENROLLING_BY_INVITATION
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:
This trial is a single-center non-blind two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens high-dose cytarabine plus daunorubicin HDAC vs cytarabine plus high-dose daunorubicin AD in acute myeloid leukemia AML The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival EFS time from registration to induction failure relapse or death
Detailed Description:
Induction chemotherapy
Arm I HDAC cytarabine 30 gm2 q12hr 3-hour iv infusion on days 1 3 5 plus daunorubicin 45 mgm2day continuous iv infusion for 3 days D1-3
Arm II AD cytarabine 200 mgm2day continuous iv infusion for 7 days D1-7 plus daunorubicin 90 mgm2day continuous iv infusion for 3 days D1-3
Interim bone marrow examination Interim bone marrow aspiration and biopsy will be done between 14 and 21 days after start of induction chemotherapy If bone marrow has blasts 10 no additional chemotherapy will be given until the recovery of blood counts absolute neutrophil counts rise over 1000μL and platelet counts over 100000μL or post-induction day 35 when bone marrow examination will be repeated to evaluate CR After the marrow examination re-induction course will be given If interim bone marrow examination shows persistent leukemia blasts 10 re-induction course could be given Patients who did not attain CR after the re-induction chemotherapy will be eliminated from the study
Re-induction chemotherapy
Cytarabine 200 mgm2day iv infusion for 5 days D1-5 plus daunorubicin 45 mgm2day iv infusion for 2 days D1-2 Post-remission consolidation chemotherapy
Adverse risk group up to 3 courses of intermediate-dose cytarabine 10 gm2day iv for 5 days D1-5 plus etoposide 150 mgm2day iv for 3 days D1-3
Favorableintermediate risk group up to 3 courses of high-dose cytarabine 30 gm2day q12 hr iv for 3 days D1 3 5
Autologous or allogeneic hematopoietic cell transplantation HCT can be performed based on the risk of relapse
The bone marrow examination will be done after the completion of consolidation chemotherapy or before HCT
Arm I HDAC cytarabine 30 gm2 q12hr 3-hour iv infusion on days 1 3 5 plus daunorubicin 45 mgm2day continuous iv infusion for 3 days D1-3
Arm II AD cytarabine 200 mgm2day continuous iv infusion for 7 days D1-7 plus daunorubicin 90 mgm2day continuous iv infusion for 3 days D1-3
Interim bone marrow examination Interim bone marrow aspiration and biopsy will be done between 14 and 21 days after start of induction chemotherapy If bone marrow has blasts 10 no additional chemotherapy will be given until the recovery of blood counts absolute neutrophil counts rise over 1000μL and platelet counts over 100000μL or post-induction day 35 when bone marrow examination will be repeated to evaluate CR After the marrow examination re-induction course will be given If interim bone marrow examination shows persistent leukemia blasts 10 re-induction course could be given Patients who did not attain CR after the re-induction chemotherapy will be eliminated from the study
Re-induction chemotherapy
Cytarabine 200 mgm2day iv infusion for 5 days D1-5 plus daunorubicin 45 mgm2day iv infusion for 2 days D1-2 Post-remission consolidation chemotherapy
Adverse risk group up to 3 courses of intermediate-dose cytarabine 10 gm2day iv for 5 days D1-5 plus etoposide 150 mgm2day iv for 3 days D1-3
Favorableintermediate risk group up to 3 courses of high-dose cytarabine 30 gm2day q12 hr iv for 3 days D1 3 5
Autologous or allogeneic hematopoietic cell transplantation HCT can be performed based on the risk of relapse
The bone marrow examination will be done after the completion of consolidation chemotherapy or before HCT
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