Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia

PRIMARY OBJECTIVES:

I. To provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia
(APL), who have relapsed or who are refractory to standard treatments, with access to
gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative therapy
is available.

II. To carefully monitor safety and to report safety information from patients receiving
Mylotarg in this setting.

OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.

After completion of study treatment, patients are followed up every month for 1 year.

Inclusion Criteria:

- Diagnosis of relapsed or refractory AML and not candidate for standard consolidation
treatment after daunorubicin and cytosine arabinoside OR diagnosis of APL relapsed
after tretinoin (ATRA) and arsenic trioxide therapy or APL with persisting or rising
blasts, and no other comparable or satisfactory alternative therapy available
(including patients not eligible for, or who have access to, investigational therapies
via a clinical trial)

- Patients must have an initial diagnosis of AML, biphenotypic acute leukemia, or APL

- Patients must have cluster of differentiation (CD)33 positivity of > 30%

- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 / Karnofsky > 60%

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2 x institutional upper limit of normal

- It is deemed ethical to provide an experimental drug (e.g., Mylotarg) that is
associated with hepatotoxicity (veno-occlusive disease [VOD]) and myelosuppression

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to receiving Mylotarg
and for the duration of treatment; should a woman become pregnant or suspect she is
pregnant while receiving treatment with Mylotarg, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written Institutional Review Board
(IRB)-approved informed consent document

Exclusion Criteria:

- Patients may not currently be receiving any other investigational agents for leukemia

- Patients with known untreated hepatitis C

- Uncontrolled intercurrent illness including, but not limited to active liver disease,
or psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with Mylotarg

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible; appropriate studies will be undertaken in patients receiving
combination antiretroviral therapy when indicated

- Patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts:
recombinant humanized anti-CD33 monoclonal (hP67.6) antibody, calicheamicin
derivatives or other ingredients