Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00003602
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
Riverside Haematology Group
Organization:
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?: