Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the complete remission rate (CR). Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy. Further evaluate the toxicity of this regimen. OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Official Title
-----------------
Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: cytarabine
* Drug: idarubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Inclusion criteria: Newly diagnosed acute myeloid leukemia (AML) Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease Previously untreated with radiotherapy or chemotherapy Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy Patients with prior myelodysplastic syndrome are eligible Extramedullary leukemia allowed AML with lymphoid markers allowed Exclusion criteria: Blastic transformation of chronic myelogenous leukemia Biphenotypic leukemia FAB M3 disease (acute promyelocytic leukemia) PATIENT CHARACTERISTICS: Life expectancy ≥ 6 weeks Total bilirubin < 1.5 g/dL AST and ALT < 5 times upper limit of normal (ULN) Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration HIV antibody-negative PRIOR CONCURRENT THERAPY: Inclusion criteria: See Disease Characteristics Prior hydroxyurea or corticosteroids allowed At least 48 hours since prior and no concurrent itraconazole or fluconazole Exclusion criteria: More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (idarubicin, cytarabine)<br>Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin. | Drug: cytarabine<br> <br> * Other names: Depocyt;Drug: idarubicin<br> <br> * Other names: Zavedos;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission (CR) | The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable. | 7 days post completion of induction chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Marrow at Day 7 Post-Induction Chemotherapy | Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%) | 7 days post completion of induction chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia