Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00052299
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.
PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
* Determine the antileukemic activity of standard induction chemotherapy with or without gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid leukemia.
* Determine the overall survival of patients treated with these regimens.
* Determine the rate of response, disease-free survival, event-free survival, incidence of relapse, and incidence of death of patients treated with these regimens.
* Determine the rate, type, and grade of toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (61-69 vs 70-75), CD33 positivity (less than 5% vs 5-19% vs 20-80% vs more than 80% vs unknown), initial WBC before hydroxyurea administration if needed (less than 30,000/mm\^3 vs at least 30,000/mm\^3), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I:
* Induction (phase I): Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15.
* Induction (phase II/MICE regimen): Beginning between days 50 and 53, patients receive mitoxantrone IV over 30 minutes on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-7. Bone marrow evaluation is performed on day 29. Patients with partial remission (PR) receive a second course of MICE chemotherapy regimen. Patients with complete remission (CR) after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy.
* Consolidation: Beginning within 4 weeks of documentation of CR, patients receive gemtuzumab ozogamicin IV over 2 hours on day 0; idarubicin IV on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-5. After at least day 30, patients receive a second consolidation course in the absence of disease progression or unacceptable toxicity.
* Arm II:
* Induction (MICE regimen): Patients receive mitoxantrone, etoposide, and cytarabine as in arm I induction. Bone marrow evaluation is performed on day 29. Patients with PR receive a second course of MICE chemotherapy regimen. Patients with CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy.
* Consolidation: Patients receive idarubicin, etoposide, and cytarabine as in arm I consolidation.
Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this study within 3.75 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM A mitoxantrone hydrochloride GO + MICE for remission induction followed by GO + mini-ICE for consolidation ARM B mitoxantrone hydrochloride MICE for remission induction followed by mini-ICE for consolidation ARM A cytarabine GO + MICE for remission induction followed by GO + mini-ICE for consolidation ARM A etoposide GO + MICE for remission induction followed by GO + mini-ICE for consolidation ARM A gemtuzumab ozogamicin GO + MICE for remission induction followed by GO + mini-ICE for consolidation ARM A idarubicin GO + MICE for remission induction followed by GO + mini-ICE for consolidation ARM B cytarabine MICE for remission induction followed by mini-ICE for consolidation ARM B idarubicin MICE for remission induction followed by mini-ICE for consolidation ARM B etoposide MICE for remission induction followed by mini-ICE for consolidation
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction Disease-free survival after CR/CRp Event-free survival Toxicity (highest grade) assessed by International Working Group CTC v2.0 Incidence of relapse after CR/CRp Incidence of death without relapse after CR/CRp
Trial Locations
- Locations (55)
Ospedale San Bortolo
🇮🇹Vicenza, Italy
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
🇦🇹Linz, Austria
Ospedale Civile Umberto I
🇮🇹Mestre, Italy
Ospedale San Martino
🇮🇹Genoa, Italy
Institut Jules Bordet
🇧🇪Brussels, Belgium
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Papardo
🇮🇹Messina, Italy
Azienda Ospedaliera - Universitaria di Modena
🇮🇹Modena, Italy
Universita degli Studi di Messina
🇮🇹Messina, Italy
Ospedale Cervello
🇮🇹Palermo, Italy
Azienda Ospedale - d "S. Salvatore"
🇮🇹Pesaro, Italy
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Ruprecht - Karls - Universitaet Heidelberg
🇩🇪Heidelberg, Germany
Azienda Sanitaria di Bolzano
🇮🇹Bolzano, Italy
Ospedale Civile Pescara
🇮🇹Pescara, Italy
Libero Istituto Universitario Campus Bio-Medico
🇮🇹Rome, Italy
Maxima Medisch Centrum - Veldhoven
🇳🇱Veldhoven, Netherlands
AZ Sint-Jan
🇧🇪Brugge, Belgium
Ospedale S. Antonio Abate
🇮🇹Gallarate Varese, Italy
Hospital Escolar San Joao
🇵🇹Porto, Portugal
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels, Belgium
H. San Giovanni-Addolorata Hospital
🇮🇹Rome, Italy
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Hopital Edouard Herriot
🇫🇷Lyon, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Klinikum der Albert - Ludwigs - Universitaet Freiburg
🇩🇪Freiburg, Germany
Hotel Dieu de Paris
🇫🇷Paris, France
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Universita Degli Studi di Bari
🇮🇹Bari, Italy
Ospedale Binaghi
🇮🇹Cagliari, Italy
Ospedale Oncologico A. Businco
🇮🇹Cagliari, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy
Ospedale Regionale A. Pugliese
🇮🇹Catanzaro, Italy
Azienda Istituti Ospitalieri
🇮🇹Cremona, Italy
Universita di Ferrara
🇮🇹Ferrara, Italy
Azienda Ospedaliera "A. Cardarelli"
🇮🇹Naples, Italy
Federico II University Medical School
🇮🇹Naples, Italy
Azienda Ospedaliera Maggiore Della Carita
🇮🇹Novara, Italy
Azienda Ospedale S. Luigi at University of Torino
🇮🇹Orbassano, Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Ospedale La Maddalena - Palermo
🇮🇹Palermo, Italy
Perugia Regional Cancer Center
🇮🇹Perugia, Italy
Ospedale Sant' Eugenio
🇮🇹Rome, Italy
Universita Degli Studi "La Sapeinza"
🇮🇹Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Istituto di Ematologia Universita - University di Sassari
🇮🇹Sassari, Italy
Policlinico G. B. Rossi - Borgo Roma
🇮🇹Verona, Italy
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands