Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00006122
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- 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. Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia.
- Detailed Description
OBJECTIVES: I. Determine the feasibility, toxicity, and antileukemic activity of gemtuzumab ozogamicin (CMA-676) with or without mitoxantrone, etoposide, cytarabine, and idarubicin in elderly patients with acute myeloid leukemia.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (standard risk, defined as age 61-75 and WHO performance status 0-1 vs poor risk, defined as over 75 years and WHO performance status 0-2 OR under 76 years and WHO performance status 2). Frontline therapy: Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Stratum I (Standard risk patients): Patients with disease progression at any time during frontline therapy may begin induction therapy immediately. Induction therapy begins 7-10 days after response assessment regardless of response and in the absence of unacceptable toxicity. Stratum II (Poor risk patients): Patients experiencing complete remission with or without platelet recovery will begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity. Stratum I Induction therapy: 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. Patients experiencing partial response are given a second induction therapy course. Patients experiencing complete remission with or without platelet recovery after 1 or 2 induction courses begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity. Consolidation therapy: Patients receive 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. Stratum II Consolidation therapy: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and then 1-3 months later. Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 45-82 (28-49 for stratum I, and 17-33 for stratum II) patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Hotel Dieu de Paris
🇫🇷Paris, France
A.Z. St. Jan
🇧🇪Brugge, Belgium
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Hopital Edouard Herriot
🇫🇷Lyon, France
Hopital Necker
🇫🇷Paris, France
Ospedale Generale Regionale
🇮🇹Bolzano, Italy
Ospedali Riuniti
🇮🇹Reggio Calabria, Italy
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Azienda Policlinico Umberto Primo
🇮🇹Rome, Italy
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱's-Hertogenbosch, Netherlands
CHU Sart-Tilman
🇧🇪Liege, Belgium
University Hospital Rebro
ðŸ‡ðŸ‡·Zagreb, Croatia
Medizinische Klinik und Poliklinik
🇩🇪Heidelberg, Germany
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Ospedale San Eugenio
🇮🇹Rome, Italy
Eberhard Karls Universitaet
🇩🇪Tuebingen, Germany
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy