Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed CD33+ acute myeloid leukemia (AML)

- In first relapse from chemotherapy

- Complete response lasting at least 3 months before relapse

- No CNS leukemia

- No secondary leukemia or history of antecedent hematologic disorder prior to initial
onset of AML (e.g., myelodysplasia)

PATIENT CHARACTERISTICS:

Age:

- 60 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC less than 30,000/mm^3

- No bleeding or coagulation disorder except disease-related disseminated intravascular
coagulation

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- PT and PTT no greater than 1.5 times upper limit of normal OR

- INR no greater than 1.3

- No history of chronic hepatitis or cirrhosis

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No uncontrolled congestive heart failure

- No New York Heart Association class III or IV heart disease

Pulmonary:

- No severe pulmonary disease

Other:

- HIV negative

- No other concurrent medical disease that would preclude study entry

- No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab
ozogamicin or any of its components, E. coli protein, or any product produced in E.
coli

- No other concurrent malignancy

- No known human anti-human antibodies

- No uncontrolled seizure disorder

- No active uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior allogeneic or autologous stem cell transplantation

- No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)

Chemotherapy:

- See Disease Characteristics

- At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or
hydroxyurea

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 2 weeks since prior systemic radiotherapy

Surgery:

- At least 2 weeks since prior major surgery

- No prior organ allograft

Other:

- At least 3 weeks since prior antileukemic therapy and recovered

- No other concurrent investigational therapy

- No concurrent immunosuppressive therapy