Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002517
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN A PHASE III RANDOMIZED STUDY
Status:
COMPLETED
Status Verified Date:
2002-12
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 more than one drug may kill more cancer cells It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Compare the efficacy of idarubicin vs mitoxantrone in induction and first intensification in terms of achieving and maintaining complete remissions in children with acute myeloid leukemia or myelodysplastic syndrome
OUTLINE This is a randomized multicenter study Patients are stratified according to center and disease type de novo acute myeloid leukemia AML vs AML secondary to myelodysplastic syndrome MDS vs MDS
Induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cytarabine ARA-C IV continuously on days 1 and 2 and then IV over 30 minutes every 12 hours on days 3-8 mitoxantrone IV on days 3-5 etoposide VP-16 IV over 1 hour on days 6-8 and ARA-C intrathecally IT on days 1 and 8
Arm II Patients receive ARA-C and VP-16 as in arm I and idarubicin IV on days 3-5
Patients on both arms with CNS disease at presentation receive ARA-C IT every 3 days until the CSF clears and then weekly until the first intensification After induction patients on both arms proceed to first intensification regardless of response
First intensification When blood counts recover and within 40 days after initiating induction patients are randomized to 1 of 2 treatment arms
Arm III Patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 if allogeneic bone marrow transplantation BMT is planned or days 1-4 if allogeneic BMT is not planned and mitoxantrone IV on days 7-9
Arm IV Patients receive high-dose ARA-C as in arm III and idarubicin IV on days 7-9
Patients who achieve complete remission CR after first intensification and have an HLA-identical chronic myelomonocytic leukemia-nonreactive sibling donor undergo allogeneic BMT Patients who achieve CR after intensification and have no suitable donor receive intensive chemotherapy as defined below All patients with chloroma at presentation undergo local radiotherapy beginning after final intensification
Second intensification When blood counts recover patients receive daunorubicin IV continuously ARA-C IV continuously VP-16 IV continuously oral thioguanine and oral dexamethasone on days 1-4 and 11-14 and ARA-C IT on days 1 4 11 and 14
Third intensification When blood counts recover patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 and VP-16 IV over 1 hour on days 2-5 When blood counts recover autologous bone marrow is harvested in the event of subsequent relapse
Maintenance When blood counts recover patients receive oral thioguanine daily and ARA-C subcutaneously 4 days a month for 1 year
PROJECTED ACCRUAL A total of 310 patients will be accrued for this study within 5 years
Compare the efficacy of idarubicin vs mitoxantrone in induction and first intensification in terms of achieving and maintaining complete remissions in children with acute myeloid leukemia or myelodysplastic syndrome
OUTLINE This is a randomized multicenter study Patients are stratified according to center and disease type de novo acute myeloid leukemia AML vs AML secondary to myelodysplastic syndrome MDS vs MDS
Induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cytarabine ARA-C IV continuously on days 1 and 2 and then IV over 30 minutes every 12 hours on days 3-8 mitoxantrone IV on days 3-5 etoposide VP-16 IV over 1 hour on days 6-8 and ARA-C intrathecally IT on days 1 and 8
Arm II Patients receive ARA-C and VP-16 as in arm I and idarubicin IV on days 3-5
Patients on both arms with CNS disease at presentation receive ARA-C IT every 3 days until the CSF clears and then weekly until the first intensification After induction patients on both arms proceed to first intensification regardless of response
First intensification When blood counts recover and within 40 days after initiating induction patients are randomized to 1 of 2 treatment arms
Arm III Patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 if allogeneic bone marrow transplantation BMT is planned or days 1-4 if allogeneic BMT is not planned and mitoxantrone IV on days 7-9
Arm IV Patients receive high-dose ARA-C as in arm III and idarubicin IV on days 7-9
Patients who achieve complete remission CR after first intensification and have an HLA-identical chronic myelomonocytic leukemia-nonreactive sibling donor undergo allogeneic BMT Patients who achieve CR after intensification and have no suitable donor receive intensive chemotherapy as defined below All patients with chloroma at presentation undergo local radiotherapy beginning after final intensification
Second intensification When blood counts recover patients receive daunorubicin IV continuously ARA-C IV continuously VP-16 IV continuously oral thioguanine and oral dexamethasone on days 1-4 and 11-14 and ARA-C IT on days 1 4 11 and 14
Third intensification When blood counts recover patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 and VP-16 IV over 1 hour on days 2-5 When blood counts recover autologous bone marrow is harvested in the event of subsequent relapse
Maintenance When blood counts recover patients receive oral thioguanine daily and ARA-C subcutaneously 4 days a month for 1 year
PROJECTED ACCRUAL A total of 310 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-58921 | None | None | None |