Status:
UNKNOWN
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
61+ years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet kno...
Detailed Description
OBJECTIVES: * Compare the feasibility, toxicity, and antileukemic activity of two different dosing regimens of gemtuzumab ozogamicin (GO) vs standard supportive care in older patients with previously...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML)
- At least 20% bone marrow blasts by bone marrow aspiration or biopsy
- All subtypes except M3 (acute promyelocytic leukemia) are allowed
- Previously untreated primary or secondary disease (including AML after myelodysplastic syndromes)
- Ineligible for intensive chemotherapy, as defined by 1 of the following criteria:
- 61 to 75 years old AND WHO performance status \> 2 AND/OR unwilling to receive intensive chemotherapy
- Over 75 years old
- No blast crisis of chronic myeloid leukemia
- No AML supervention after other myeloproliferative disease
- WBC \< 30,000/mm\^3 and meets 1 of the following criteria:
- WBC \< 30,000/mm\^3 at diagnosis AND had no prior treatment with hydroxyurea
- WBC ≥ 30,000/mm\^3 at diagnosis AND received mandatory pretreatment with hydroxyurea (up to 14 days duration) until WBC \< 30,000/mm\^3
- No active CNS leukemia
- PATIENT CHARACTERISTICS:
- Age
- See Disease Characteristics
- 61 and over
- Performance status
- See Disease Characteristics
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No arrhythmia requiring chronic treatment
- No congestive heart failure
- No symptomatic ischemic heart disease
- No other severe cardiovascular disease
- Pulmonary
- No severe pulmonary dysfunction ≥ grade 3
- Other
- No alcohol abuse
- No severe neurological or psychiatric disease
- No active uncontrolled infection or severe systemic infection
- No other malignancy
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- No concurrent antiangiogenic drugs
- Chemotherapy
- See Disease Characteristics
- Concurrent low-dose cytostatic agents (i.e., thioguanine or mercaptopurine) allowed for palliative care (standard supportive care arm only)
- Endocrine therapy
- Prior corticosteroids (duration ≤ 14 days ) for primary or secondary AML allowed
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No other concurrent cytotoxic drugs
- No other concurrent experimental therapy
- No concurrent tyrosine kinase inhibitors
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT00091234
Start Date
June 1 2004
Last Update
July 24 2012
Active Locations (45)
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1
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Belgium, 2020
2
AZ Sint-Jan
Bruges, Belgium, 8000
3
Institut Jules Bordet
Brussels, Belgium, 1000
4
Hopital Universitaire Erasme
Brussels, Belgium, 1070