Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (AML-19)
Leukemia

About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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), untreated adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), 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)
Eligibility Criteria
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
Sites / Locations
- Ziekenhuis Netwerk Antwerpen MiddelheimRecruiting
- AZ Sint-JanRecruiting
- Institut Jules BordetRecruiting
- Hopital Universitaire ErasmeRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- CHU Liege - Domaine Universitaire du Sart TilmanRecruiting
- Centre Hospitalier Peltzer-La TourelleRecruiting
- Ospedale S Donato, USL-8Recruiting
- Universita Degli Studi di BariRecruiting
- Universita Di BresciaRecruiting
- Ospedale BinaghiRecruiting
- Ospedale Oncologico A. BusincoRecruiting
- Ospedale Regionale A PuglieseRecruiting
- Ospedale FerrarottoRecruiting
- Ospedale Regionale A. PuglieseRecruiting
- Universita di FerraraRecruiting
- Azienda Ospedaliera Vito FazziRecruiting
- Azienda Ospedaliera - Universitaria di ModenaRecruiting
- Ospedale Di MontefiasconeRecruiting
- Azienda Ospedaliera di Rilievo Nazionale A.CardarelliRecruiting
- Ospedale Maggiore della CaritaRecruiting
- Azienda Ospedaliera Policlinico Paolo GiacconeRecruiting
- Ospedale La Maddalena - PalermoRecruiting
- Azienda Ospedaliera Di ParmaRecruiting
- Policlinico MonteluceRecruiting
- Ospedale San SalvatoreRecruiting
- Ospedale Civile PescaraRecruiting
- Ospedale San CarloRecruiting
- Ospedale Sta. Maria Delle CrociRecruiting
- Ospedale Sant'AndreaRecruiting
- Azienda Ospedaliera Universitaria Policlinico Tor VergataRecruiting
- Ospedale Sant' EugenioRecruiting
- Libero Istituto Universitario Campus Bio-MedicoRecruiting
- Azienda Policlinico Umberto PrimoRecruiting
- Istituto Regina ElenaRecruiting
- Policlinico A. Gemelli - Universita Cattolica del Sacro CuoreRecruiting
- H. San Giovanni-Addolorata HospitalRecruiting
- Universita Degli Studi "La Sapeinza"Recruiting
- Istituto di Ematologia Universita - University di SassariRecruiting
- Universita di SienaRecruiting
- Ospedale Maggiore dell' UniversitaRecruiting
- Jeroen Bosch ZiekenhuisRecruiting
- Onze Lieve Vrouwe GasthuisRecruiting
- Leiden University Medical CenterRecruiting
- Universitair Medisch Centrum St. Radboud - NijmegenRecruiting