Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00091234
- 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 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.
- 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 untreated acute myeloid leukemia who are not candidates for intensive chemotherapy. (phase II)
* Compare the efficacy and toxicity of the best dosing regimen of GO selected from phase II vs standard supportive care, in terms of overall survival, in these patients. (phase III)
OUTLINE: This is a randomized, open-label, multicenter phase II study followed by a phase III study. Patients are stratified according to age (61 to 75 vs 76 to 80 vs 81 and over), CD33-positivity of bone marrow blasts (\< 20% vs 20-80% vs \> 80% vs unknown), initial WBC before hydroxyurea administration (\< 30,000/mm\^3 vs ≥ 30,000/mm\^3), WHO performance status (0-1 vs 2 vs 3-4), and participating center.
* Phase II: Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive gemtuzumab ozogamicin (GO) IV over 2 hours on days 1 and 8. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive GO IV over 2 hours on days 1, 3, and 5. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive standard supportive care.
* Phase III: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive the selected treatment (arm I or arm II) from phase II.
* Arm II: Patients receive standard supportive care. Patients who receive GO treatment are followed monthly for 1 year and then every 3 months thereafter. Patients who receive standard supportive care are followed at least every 4 weeks.
PROJECTED ACCRUAL: A total of 259 patients (75 for phase II \[25 per treatment arm\] and 184 for phase III \[92 per treatment arm\]) will be accrued for this study within 2.5 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 279
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients able to start continuation therapy (Phase II) Overall survival (Phase III)
- Secondary Outcome Measures
Name Time Method Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II) Overall survival (Phase II) Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III) 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) Disease-free survival for patients who reached CR or CRp (Phase III) Progression-free survival from randomization for patients in GO arm (Phase III)
Trial Locations
- Locations (45)
Ospedale Binaghi
🇮🇹Cagliari, Italy
Ospedale Oncologico A. Businco
🇮🇹Cagliari, Italy
Ospedale Di Montefiascone
🇮🇹Montefiascone, Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Ospedale Sta. Maria Delle Croci
🇮🇹Ravenna, Italy
Ospedale S Donato, USL-8
🇮🇹Arezzo cap, Italy
Universita Degli Studi di Bari
🇮🇹Bari, Italy
Universita Di Brescia
🇮🇹Brescia, Italy
Ospedale Sant' Eugenio
🇮🇹Rome, Italy
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Ospedale Regionale A Pugliese
🇮🇹Cantanzaro, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy
Universita di Ferrara
🇮🇹Ferrara, Italy
Azienda Ospedaliera Vito Fazzi
🇮🇹Lecce, Italy
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Ospedale Civile Pescara
🇮🇹Pescara, Italy
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Ospedale La Maddalena - Palermo
🇮🇹Palermo, Italy
Ospedale San Carlo
🇮🇹Potenza, Italy
Ospedale Regionale A. Pugliese
🇮🇹Catanzaro, Italy
Azienda Ospedaliera - Universitaria di Modena
🇮🇹Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
🇮🇹Naples, Italy
Ospedale Maggiore della Carita
🇮🇹Novara, Italy
Policlinico Monteluce
🇮🇹Perugia, Italy
Ospedale San Salvatore
🇮🇹Pesaro, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
🇮🇹Rome, Italy
Istituto di Ematologia Universita - University di Sassari
🇮🇹Sassari, Italy
Universita di Siena
🇮🇹Siena, Italy
Libero Istituto Universitario Campus Bio-Medico
🇮🇹Rome, Italy
Azienda Policlinico Umberto Primo
🇮🇹Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
H. San Giovanni-Addolorata Hospital
🇮🇹Rome, Italy
Universita Degli Studi "La Sapeinza"
🇮🇹Rome, Italy
Ospedale Maggiore dell' Universita
🇮🇹Trieste, Italy
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
Ospedale Sant'Andrea
🇮🇹Roma, Italy
Istituto Regina Elena
🇮🇹Rome, Italy
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium