Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00860639
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2009-03-11
Brief Title:
Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia AML With Intermediate Risk
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin MYLOTARG Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia AML With Intermediate Risk
Status:
COMPLETED
Status Verified Date:
2017-01
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:
LAM2006IR
Brief Summary:
The main objective of the study is to improve outcome of younger patients between 18-60 years with acute myeloid leukemia and intermediate risk defined by the cytogenetics In this population in the absence of bone marrow transplantation event free survival EFS is estimated at 35 after three years of follow-up Adjunction of gemtuzumab ozogamycin MYLOTARG to standard chemotherapy is supposed to increase EFS up to 50 at 3 years To test this hypothesis the Groupe Ouest Est dEtude des Leucémies et Autres Maladies du Sang GOELAMS sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers
Detailed Description:
Initial randomization will be completed upon receipt of karyotype results and will determine the administration of gemtuzumab ozogamycin MYLOTARG in combination with chemotherapy during the induction course and the first intensive consolidation course The induction course include Daunorubicin for 3 days 60mgm² associated with cytarabine 200mgm² for 7 days The MYLOTARG will be administered according to the randomization arm on the 4th day of treatment by slow intravenous infusion of 2 hours at a dose of 6 mgm2 Early bone marrow assessment will be performed at D15 In case of blast excess 5 a second course of induction will be administered
The consolidation treatment depends on age molecular prognostic factors and donor availability
Patients with good molecular prognosis profile NPM1 FLT3 ITD - or CEBPa mutated will be consolidated by two courses of intensive chemotherapy comprising Mitoxanthrone and intermediate dose of Cytarabine with or without MYLOTARG according to the initial randomization during the first course
Patients younger than 51 years eligible for standard allogeneic transplantation with sibling or full matched unrelated donor will receive a standard bone marrow transplantation which not begin before 90 days after the induction
Patients with no donor or older than 50 years or with a donor being identified will receive two courses of intensive consolidation comprising Mitoxantrone and intermediate-dose of Cytarabine with or without Mylotarg 6 mg m² during the first consolidation according to the randomisation arm
Patients aged 51 to 60 years with an HLA identical donor sibling or unrelated will receive a non-myeloablative haematopoietic stem cells transplant HSCT after the second course of consolidation
For other patients an autologous hematopoietic stem cells transplant HSCT will be performed after the 2nd course of consolidation Collection of peripheral blood stem cells PBSCs will be performed after the first consolidation course and a second collection may be considered after the second consolidation course in case of inadequate collection
The consolidation treatment depends on age molecular prognostic factors and donor availability
Patients with good molecular prognosis profile NPM1 FLT3 ITD - or CEBPa mutated will be consolidated by two courses of intensive chemotherapy comprising Mitoxanthrone and intermediate dose of Cytarabine with or without MYLOTARG according to the initial randomization during the first course
Patients younger than 51 years eligible for standard allogeneic transplantation with sibling or full matched unrelated donor will receive a standard bone marrow transplantation which not begin before 90 days after the induction
Patients with no donor or older than 50 years or with a donor being identified will receive two courses of intensive consolidation comprising Mitoxantrone and intermediate-dose of Cytarabine with or without Mylotarg 6 mg m² during the first consolidation according to the randomisation arm
Patients aged 51 to 60 years with an HLA identical donor sibling or unrelated will receive a non-myeloablative haematopoietic stem cells transplant HSCT after the second course of consolidation
For other patients an autologous hematopoietic stem cells transplant HSCT will be performed after the 2nd course of consolidation Collection of peripheral blood stem cells PBSCs will be performed after the first consolidation course and a second collection may be considered after the second consolidation course in case of inadequate collection
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