Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study
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
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.
Primary Purpose: Treatment
Sergio Amadori, MD
Ospedale Sant' Eugenio
United States: Federal Government