Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480064
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2007-05-29
Brief Title:
Lomustine and Intermediate Dose Cytarabine in Older Patients With AML
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia
Status:
COMPLETED
Status Verified Date:
2007-05
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:
A multicenter randomized trial was performed comparing induction therapy IC Idarubicin and Cytarabine 57 to ICL the same drugs plus lomustine CCNU 200mgm2 orally at day 1 Patients in complete remission CR were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy
Detailed Description:
Induction therapy Patients were randomized to receive idarubicin plus cytarabine IC or the same drugs plus lomustine ICL the latter given at the dose of 200 mgm2 orally at day 1 Patients with persistent leukemia in the bone marrow defined by at least 20 marrow cellularity with more than 5 blasts on day 14 or at a subsequent time point following initiation of induction therapy received a second course of induction chemotherapy identical to the initial induction course Non-responders to the second induction course were taken off the protocol
Consolidation therapy After completing induction treatment patients who were in complete remission after 1 or 2 induction courses received a course of consolidation IC therapy with idarubicin and subcutaneous cytarabine Subsequently if stable remission persisted the patients received maintenance therapy or maintenance therapy preceded by a second consolidation IIC with intermediate-dose cytarabine Randomization was performed as soon as CR was achieved
Maintenance therapy This was conducted in all patients with persisting CR one month after completing the first IC or second IIC consolidation and consisted of the following five courses of combination chemotherapy at 1 3 6 9 and 13 months from the last consolidation namely cytarabine subcutaneously and idarubicin and between these courses for one year a continuous regimen of methotrexate and 6-mercaptopurine as alternating 10 day-courses
Consolidation therapy After completing induction treatment patients who were in complete remission after 1 or 2 induction courses received a course of consolidation IC therapy with idarubicin and subcutaneous cytarabine Subsequently if stable remission persisted the patients received maintenance therapy or maintenance therapy preceded by a second consolidation IIC with intermediate-dose cytarabine Randomization was performed as soon as CR was achieved
Maintenance therapy This was conducted in all patients with persisting CR one month after completing the first IC or second IIC consolidation and consisted of the following five courses of combination chemotherapy at 1 3 6 9 and 13 months from the last consolidation namely cytarabine subcutaneously and idarubicin and between these courses for one year a continuous regimen of methotrexate and 6-mercaptopurine as alternating 10 day-courses
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