Clinical trial NCT00528398: Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
Official title: Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-12
Enrollment: 111
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete Remission (CR)
timeFrame: 7 days post completion of induction chemotherapy
Secondary outcomes:
measure: Bone Marrow at Day 7 Post-Induction Chemotherapy
timeFrame: 7 days post completion of induction chemotherapy
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Anthony S. Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: