Leukemia
Conditions
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
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.
Interventions
DRUGcytarabine
DRUGidarubicin
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission (CR) | 7 days post completion of induction chemotherapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Marrow at Day 7 Post-Induction Chemotherapy | 7 days post completion of induction chemotherapy | Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Idarubicin, Cytarabine) All patients were analyzed together. | 111 |
| Total | 111 |
Baseline characteristics
| Characteristic | Treatment (Idarubicin, Cytarabine) |
|---|---|
| Age, Continuous | 43 years |
| Diagnosis AML Evolved from MDS | 25 Participants |
| Diagnosis AML Secondary to Chemotherapy | 6 Participants |
| Diagnosis De Novo AML | 80 Participants |
| Gender Female | 50 Participants |
| Gender Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 95 / 111 |
| serious Total, serious adverse events | 51 / 111 |
Outcome results
Primary
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.
Time frame: 7 days post completion of induction chemotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Idarubicin, Cytarabine) | Complete Remission (CR) | CR | 77 Participants |
| Treatment (Idarubicin, Cytarabine) | Complete Remission (CR) | No CR | 32 Participants |
| Treatment (Idarubicin, Cytarabine) | Complete Remission (CR) | Unknown | 2 Participants |
Secondary
Bone Marrow at Day 7 Post-Induction Chemotherapy
Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)
Time frame: 7 days post completion of induction chemotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Idarubicin, Cytarabine) | Bone Marrow at Day 7 Post-Induction Chemotherapy | Positive for Leukemia | 17 Participants |
| Treatment (Idarubicin, Cytarabine) | Bone Marrow at Day 7 Post-Induction Chemotherapy | Negative for Leukemia | 90 Participants |
| Treatment (Idarubicin, Cytarabine) | Bone Marrow at Day 7 Post-Induction Chemotherapy | Unknown | 4 Participants |