Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003602
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
Riverside Haematology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Study Comparing an Oral Regimen Idarubicin and Etoposide With an Intravenous Regimen MAE for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission
Status:
UNKNOWN
Status Verified Date:
2001-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission
Detailed Description:
OBJECTIVES
Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone etoposide and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission
Compare the toxicity of these 2 regimens in these patients
Assess the quality of life of these patients
OUTLINE This is a randomized study Patients are stratified according to number of courses of induction therapy required to achieve complete remission
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7 Patients receive 1-2 courses of induction chemotherapy to achieve complete remission
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission
Arm I Patients receive 2 courses of mitoxantrone IV on days 1 and 2 etoposide IV over 1 hour on days 1-5 and cytarabine IV over 12 hours on days 1-5
Arm II Patients receive 2 courses of oral idarubicin and etoposide on days 1-3
Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy
Patients are followed until death
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study
Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone etoposide and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission
Compare the toxicity of these 2 regimens in these patients
Assess the quality of life of these patients
OUTLINE This is a randomized study Patients are stratified according to number of courses of induction therapy required to achieve complete remission
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7 Patients receive 1-2 courses of induction chemotherapy to achieve complete remission
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission
Arm I Patients receive 2 courses of mitoxantrone IV on days 1 and 2 etoposide IV over 1 hour on days 1-5 and cytarabine IV over 12 hours on days 1-5
Arm II Patients receive 2 courses of oral idarubicin and etoposide on days 1-3
Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy
Patients are followed until death
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-98031 | None | None | None |
| RHG-AML97 | None | None | None |