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


Phase 2
16 Years
60 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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


OBJECTIVES:

- Determine the complete remission rate (CR), and compare this rate to the historical
control group rate of 79% from our previous study achieved utilizing high-dose
cytarabine and daunorubicin.

- Determine the proportion of patients who are bone marrow-positive at day 7
post-induction chemotherapy, and compare this rate to the historical control group rate
of 20%.

- Determine the ability of patients treated with this regimen to receive further
post-remission chemotherapy, and compare this rate to historical control group rate of
81% among 79 patients achieving CR in our previous study.

- Further evaluate the toxicity of this regimen, and contrast this with our previous
study results.

- Determine the effect of prognostic variables on achieving a complete remission (e.g.,
age, WBC, FAB type, cytogenetics, and CD34).

- Describe the CR rate, proportion of patients whose bone marrow is positive at day 7
post-induction chemotherapy, ability to receive further post-remission chemotherapy,
and toxicity in 2 subgroups of patients (patients with prior myelodysplastic syndrome
and patients with treatment-related leukemia).

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.

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

Exclusion criteria:

- More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) rate

Outcome Time Frame:

Up to 20 years

Safety Issue:

No

Principal Investigator

Anthony S. Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

93139

NCT ID:

NCT00528398

Start Date:

March 1994

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006