Leukemia Clinical Trial
— AML-19Official title:
Gemtuzumab Ozogamicin (GO) Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy: A Randomized Phase II/III Trial (AML-19) of the EORTC-LG and GIMEMA-ALWP
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 known whether gemtuzumab ozogamicin is more effective than standard supportive
care in treating older patients who have acute myeloid leukemia.
PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin
regimens to see how well they work compared to standard supportive care in treating older
patients with previously untreated acute myeloid leukemia.
Status | Recruiting |
Enrollment | 279 |
Est. completion date | |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 61 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Netwerk Antwerpen Middelheim | Antwerp | |
Belgium | AZ Sint-Jan | Brugge | |
Belgium | Hopital Universitaire Erasme | Brussels | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Belgium | Centre Hospitalier Peltzer-La Tourelle | Verviers | |
Italy | Ospedale S Donato, USL-8 | Arezzo cap | |
Italy | Universita Degli Studi di Bari | Bari | |
Italy | Universita Di Brescia | Brescia | |
Italy | Ospedale Binaghi | Cagliari | |
Italy | Ospedale Oncologico A. Businco | Cagliari | |
Italy | Ospedale Regionale A Pugliese | Cantanzaro | |
Italy | Ospedale Ferrarotto | Catania | |
Italy | Ospedale Regionale A. Pugliese | Catanzaro | |
Italy | Universita di Ferrara | Ferrara | |
Italy | Azienda Ospedaliera Vito Fazzi | Lecce | |
Italy | Azienda Ospedaliera - Universitaria di Modena | Modena | |
Italy | Ospedale Di Montefiascone | Montefiascone | |
Italy | Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli | Naples | |
Italy | Ospedale Maggiore della Carita | Novara | |
Italy | Azienda Ospedaliera Policlinico Paolo Giaccone | Palermo | |
Italy | Ospedale La Maddalena - Palermo | Palermo | |
Italy | Azienda Ospedaliera Di Parma | Parma | |
Italy | Policlinico Monteluce | Perugia | |
Italy | Ospedale San Salvatore | Pesaro | |
Italy | Ospedale Civile Pescara | Pescara | |
Italy | Ospedale San Carlo | Potenza | |
Italy | Ospedale Sta. Maria Delle Croci | Ravenna | |
Italy | Ospedale Sant'Andrea | Roma | |
Italy | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | |
Italy | Azienda Policlinico Umberto Primo | Rome | |
Italy | H. San Giovanni-Addolorata Hospital | Rome | |
Italy | Istituto Regina Elena | Rome | |
Italy | Libero Istituto Universitario Campus Bio-Medico | Rome | |
Italy | Ospedale Sant' Eugenio | Rome | |
Italy | Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | |
Italy | Universita Degli Studi "La Sapeinza" | Rome | |
Italy | Istituto di Ematologia Universita - University di Sassari | Sassari | |
Italy | Universita di Siena | Siena | |
Italy | Ospedale Maggiore dell' Universita | Trieste | |
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Belgium, Italy, Netherlands,
Amadori S, Suciu S, Selleslag D, Aversa F, Gaidano G, Musso M, Annino L, Venditti A, Voso MT, Mazzone C, Magro D, De Fabritiis P, Muus P, Alimena G, Mancini M, Hagemeijer A, Paoloni F, Vignetti M, Fazi P, Meert L, Ramadan SM, Willemze R, de Witte T, Baron — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients able to start continuation therapy (Phase II) | No | ||
Primary | Overall survival (Phase III) | |||
Secondary | Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II) | No | ||
Secondary | Overall survival (Phase II) | No | ||
Secondary | Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III) | No | ||
Secondary | Rate of complete remisison (CR+CRp) by the end of induction and by the end of continuation therapy, for patients in GO arm (Phase III) | Yes | ||
Secondary | Disease-free survival for patients who reached CR or CRp (Phase III) | |||
Secondary | Progression-free survival from randomization for patients in GO arm (Phase III) |
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