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