Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Study Overview
=================
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.

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.

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

Conditions
-----------------
Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: cytarabine
* Drug: etoposide
* Drug: idarubicin
* Drug: mitoxantrone hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed de novo or secondary acute myeloid leukemia (AML) Prior myelodysplasia allowed Refractory anemia with excess blasts (RAEB) OR RAEB in transformation No relapsed AML No chronic granulocytic leukemia in transformation No CNS disease PATIENT CHARACTERISTICS: Age: Over 55 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminases no greater than 2.5 times ULN Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No severe or uncontrolled cardiac failure Other: No serious medical, social, or psychological condition Not HIV 1 or 2 seropositive PRIOR CONCURRENT THERAPY: Biologic therapy: No plan for future autograft Chemotherapy: No prior chemotherapy for myelodysplastic syndrome or AML Endocrine therapy: Not specifed Radiotherapy: Not specified Surgery: Not specified Other: No concurrent aluminum or magnesium-based antacids

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cytarabine|nan|
|Drug: etoposide|nan|
|Drug: idarubicin|nan|
|Drug: mitoxantrone hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes