Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003436
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Medical Research Council Working Party on Leukaemia in Childhood Acute Myeloid Leukaemia Trial 12
Status:
COMPLETED
Status Verified Date:
2000-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells It is not yet known whether chemotherapy is more effective with or without bone marrow transplantation for acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without bone marrow transplantation in treating children who have acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without bone marrow transplantation in treating children who have acute myeloid leukemia
Detailed Description:
OBJECTIVES
Compare two induction schedules with respect to achievement and duration of remission survival toxicity and supportive care requirements in children with previously untreated acute myeloid leukemia
Compare 4 versus 5 courses of treatment in total where the final course is either chemotherapy or bone marrow transplantation with respect to remission duration relapse rates deaths in remission and overall survival in these patients
Compare the value of allogeneic bone marrow transplantation versus conventional chemotherapy with respect to remission duration relapse rates deaths in remission and overall survival in these patients
Reduce toxicity without compromising survival by restricting the number of patients receiving bone marrow transplant in this study
OUTLINE This is a randomized study Patients are first randomized to one of two induction treatment arms
Induction Arm I Patients receive 2 courses of cytarabine IV push every 12 hours on days 1-10 or 1-8 20 or 16 doses daunorubicin IV over 6 hours on days 1 3 and 5 and etoposide IV over 4 hours on days 1-5 5 doses
Induction Arm II Patients receive 2 courses of mitoxantrone IV over 6 hours on days 1 3 and 5 cytarabine IV push every 12 hours on days 1-10 or 1-8 20 or 16 doses and etoposide IV over 4 hours on days 1-5 5 doses
Patients with no CNS disease at diagnosis receive 3 courses of triple intrathecal therapy methotrexate cytarabine and hydrocortisone one after each of the first 3 courses of chemotherapy Patients with CNS disease receive at least 6 courses of intrathecal therapy 2 courses per week then monthly courses until the final course of chemotherapy is complete
Patients in complete response after induction course 2 continue on this study Patients not in complete response after induction course 2 are taken off study and are eligible for the current Medical Research Council MRC refractoryrelapse study or another therapy
Course 3 All patients continuing on this study receive amsacrine IV over 1 hour daily on days 1-5 cytarabine continuous IV infusion daily on days 1-5 and etoposide IV over 4 hours on days 1-5 as course 3 After course 3 patients are assigned to two risk groups good risk patients and standard and poor risk patients
Standard and poor risk patients with no matched sibling donor and good risk patients are then further randomized to consolidation in arms I or II
Arm I Patients receive mitoxantrone IV over 6 hours on days 1-5 and cytarabine IV over 2 hours every 12 hours on days 1-3 4 courses of chemotherapy total
Arm II Patients receive cytarabine IV over 3 hours every 12 hours on days 1 2 8 and 9 and asparaginase subcutaneous infusion 3 hours after completion of the last cytarabine doses on days 2 and 9 followed by a course of mitoxantrone and cytarabine as in arm I 5 courses of chemotherapy total
Standard and poor risk children with matched sibling donor are randomized to arms III or IV
Arm III Patients receive no consolidation treatment 3 courses of chemotherapy total plus bone marrow transplantation
Arm IV Patients receive cytarabine and asparaginase as in arm II 4 courses of chemotherapy total plus bone marrow transplantation
Patients are followed for at least 1 year
PROJECTED ACCRUAL Approximately 2000 patients will be accrued into this study over 5 years
Compare two induction schedules with respect to achievement and duration of remission survival toxicity and supportive care requirements in children with previously untreated acute myeloid leukemia
Compare 4 versus 5 courses of treatment in total where the final course is either chemotherapy or bone marrow transplantation with respect to remission duration relapse rates deaths in remission and overall survival in these patients
Compare the value of allogeneic bone marrow transplantation versus conventional chemotherapy with respect to remission duration relapse rates deaths in remission and overall survival in these patients
Reduce toxicity without compromising survival by restricting the number of patients receiving bone marrow transplant in this study
OUTLINE This is a randomized study Patients are first randomized to one of two induction treatment arms
Induction Arm I Patients receive 2 courses of cytarabine IV push every 12 hours on days 1-10 or 1-8 20 or 16 doses daunorubicin IV over 6 hours on days 1 3 and 5 and etoposide IV over 4 hours on days 1-5 5 doses
Induction Arm II Patients receive 2 courses of mitoxantrone IV over 6 hours on days 1 3 and 5 cytarabine IV push every 12 hours on days 1-10 or 1-8 20 or 16 doses and etoposide IV over 4 hours on days 1-5 5 doses
Patients with no CNS disease at diagnosis receive 3 courses of triple intrathecal therapy methotrexate cytarabine and hydrocortisone one after each of the first 3 courses of chemotherapy Patients with CNS disease receive at least 6 courses of intrathecal therapy 2 courses per week then monthly courses until the final course of chemotherapy is complete
Patients in complete response after induction course 2 continue on this study Patients not in complete response after induction course 2 are taken off study and are eligible for the current Medical Research Council MRC refractoryrelapse study or another therapy
Course 3 All patients continuing on this study receive amsacrine IV over 1 hour daily on days 1-5 cytarabine continuous IV infusion daily on days 1-5 and etoposide IV over 4 hours on days 1-5 as course 3 After course 3 patients are assigned to two risk groups good risk patients and standard and poor risk patients
Standard and poor risk patients with no matched sibling donor and good risk patients are then further randomized to consolidation in arms I or II
Arm I Patients receive mitoxantrone IV over 6 hours on days 1-5 and cytarabine IV over 2 hours every 12 hours on days 1-3 4 courses of chemotherapy total
Arm II Patients receive cytarabine IV over 3 hours every 12 hours on days 1 2 8 and 9 and asparaginase subcutaneous infusion 3 hours after completion of the last cytarabine doses on days 2 and 9 followed by a course of mitoxantrone and cytarabine as in arm I 5 courses of chemotherapy total
Standard and poor risk children with matched sibling donor are randomized to arms III or IV
Arm III Patients receive no consolidation treatment 3 courses of chemotherapy total plus bone marrow transplantation
Arm IV Patients receive cytarabine and asparaginase as in arm II 4 courses of chemotherapy total plus bone marrow transplantation
Patients are followed for at least 1 year
PROJECTED ACCRUAL Approximately 2000 patients will be accrued into this study over 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98010 | None | None | None |
| MRC-LEUK-AML12CH | None | None | None |